Clinical Trials

IMPORTANT!

Clinical trials listed for ITP are a starting point for discussion with a health care professional. Be sure you understand all the implications of the proposed treatment and read the informed consent very carefully before enrolling in a clinical trial.

Breakdown for each trial:
• Name of trial
• Short summary
• Countries recruiting
• Link to trial page on clinicaltrials.gov
• Trial Status

List of Clinical Trials

In alphabetical order by Country

Australia

Primary immune thrombocytopenia (ITP) is an uncommon disease characterised by a low platelet count, which may cause the patient to have a higher risk or increased duration of bleeding. By creating this disease registry, this study will be able to build a more complete picture of ITP, including treatment practices, through collecting information about the condition from patients across several hospitals in several countries.

Australia, Colombia, Republic of Korea, Kuwait, Malaysia, Singapore, Taiwan, Thailand, Turkey, Uruguay

https://clinicaltrials.gov/ct2/show/NCT01970189?recrs=a&cond=ITP&draw=4&rank=29

Recruiting

Australia

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia. UCB7665, Rozanolixizumab, works by binding with high-affinity to human neonatal Fc receptor (FcRn), selectively inhibiting IgG rescue and recycling.

Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Italy, Lithuania, Republic of Moldova, Poland, Romania, Spain, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02718716?recrs=a&cond=ITP&draw=1&rank=33

Recruiting

Austria

This Phase 2 trial is underway to determine the safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in patients with primary immune thrombocytopenia. The primary focus of this study is to determine if this treatment lowers incidence and severity of serious adverse events. ARGX-113, Efgartigimod, works by degrading circulating disease-causing autoimmune antibodies.

United Kingdom, Austria, Belgium, France, Germany, Hungary, Poland, Spain, Ukraine, Czechia

https://clinicaltrials.gov/ct2/show/NCT03102593?term=ARGX-113&recrs=a&rank=2

Recruiting

Belgium

This Phase 2 trial is underway to determine the safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in patients with primary immune thrombocytopenia. The primary focus of this study is to determine if this treatment lowers incidence and severity of serious adverse events. ARGX-113, Efgartigimod, works by degrading circulating disease-causing autoimmune antibodies.

United Kingdom, Austria, Belgium, France, Germany, Hungary, Poland, Spain, Ukraine, Czechia

https://clinicaltrials.gov/ct2/show/NCT03102593?term=ARGX-113&recrs=a&rank=2

Recruiting

Bulgaria

Principia Biopharma is conducting a study of their oral drug PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options and have a platelet count <30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment begins. Preclinical findings show that PRN1008 decreases the activity of B cells and other inflammatory-causing immune cells, and in a mouse model of ITP show that PRN1008 can reduce platelet loss.

USA, Bulgaria, Czech Republic, and United Kingdom

https://clinicaltrials.gov/ct2/show/NCT03395210?term=PRN1008&rank=1

Recruiting

 

Belgium

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia. UCB7665, Rozanolixizumab, works by binding with high-affinity to human neonatal Fc receptor (FcRn), selectively inhibiting IgG rescue and recycling.

Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Italy, Lithuania, Republic of Moldova, Poland, Romania, Spain, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02718716?recrs=a&cond=ITP&draw=1&rank=33

Recruiting

Bulgaria

The main purpose of this study is to assess the efficacy and safety of BT595 in adult subjects with chronic ITP. The primary objective of this study is to determine the rate of subjects with a response. BT595 is an immunoglobulin therapy that has many proposed methods of action that involve the suppression of immune response.

Bulgaria

https://clinicaltrials.gov/ct2/show/NCT02859909?recrs=a&cond=ITP&draw=1&rank=10

Recruiting

Bulgaria

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia. UCB7665, Rozanolixizumab, works by binding with high-affinity to human neonatal Fc receptor (FcRn), selectively inhibiting IgG rescue and recycling.

Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Italy, Lithuania, Republic of Moldova, Poland, Romania, Spain, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02718716?recrs=a&cond=ITP&draw=1&rank=33

Recruiting

Canada

This is a study to investigate if eltrombopag can be used instead of Intravenous Immune Globulin (IVIG) in patients with ITP, to adequately raise their platelet count when they undergo minor or major surgery. Eltrombopag is a daily, oral pill approved for treatment of ITP. IVIG is a blood product frequently used to treat ITP. Patients with ITP who need surgery have to get treatment to increase their platelet count. IVIG is commonly used for this purpose but eltrombopag may be more effective and convenient for patients.

Canada

https://clinicaltrials.gov/ct2/show/NCT01621204?recrs=a&cond=ITP&draw=2&rank=18

Recruiting

Canada

Oseltamivir is an attractive drug for ITP since it specifically targets a pathophysiologic mechanism that appears to be important for the development of ITP and has a benign side effect profile compared to standard ITP therapy. This pilot, proof-of-concept, randomized controlled clinical trial has the potential to dramatically change the treatment of ITP.

Canada

https://clinicaltrials.gov/ct2/show/NCT03520049?recrs=a&cond=ITP&draw=4&rank=24

Recruiting

Canada

Idiopathic thrombocytopenia purpura (ITP) is the destruction of platelets in the body. Autoimmune hemolytic anemia (AIHA) is a rare disease characterized by the body’s premature destruction of red blood cells (hemolysis). Both of these conditions are autoimmune disorders, which means that the body’s immune system malfunctions and attacks healthy blood cells. These two disorders can occur at the same time (destruction of both red blood cells and platelets) or one disorder develops after the other. Evans syndrome is the combination of AIHA with ITP. The cause of Evans syndrome is currently unknown.
A Phase 2 clinical study of an investigational drug is seeking AIHA patients who meet certain criteria.

USA, Canada

https://clinicaltrials.gov/ct2/show/study/NCT02612558

Recruiting

China

Immune thrombocytopenia (ITP) is a heterogeneous disorder with variable clinical symptoms. Health Related Quality of Life (HRQoL) could be considered in ITP, as in numerous chronic diseases, as a method to provide information about the effects of medical interventions. Restoring and/or maintaining quality of life should be an important goal of treatment. This multicenter study using SF-36 and ITP-PAQ questionnaires to assess the HRQoL in patients with ITP in the real world, will determine the influencing factors of HRQoL so as to provide a sufficient basis for clinical decision making.

China

https://clinicaltrials.gov/ct2/show/NCT03324087?recrs=a&cond=ITP&draw=2&rank=21

Recruiting

China

It seems reasonable to assume that patients who present significant bleeding symptoms may have different quality of platelets than those without bleeding. This question was addressed in a study that examined platelet function in adult ITP patients, which try to determine whether this correlated with bleeding risk. Previous reports have suggested that measuring platelet function may help define patients at highest risk of bleeding.

China

https://clinicaltrials.gov/ct2/show/NCT03377439?recrs=a&cond=ITP&draw=2&rank=2

Recruiting

China

A multicentre, randomised, double-blind,4-stages phase III study enrolled 414 patients with chronic, previously treated ITP. Dosage of Hetrombopag olamine could be adjusted to maintain platelet counts 50~250×109/L. Hetrombopag olamine is a non-peptide thrombopoietin (TPO) receptor agonist that attempts to increase platelet production.

China

https://clinicaltrials.gov/ct2/show/NCT03222843?recrs=a&cond=ITP&draw=2&rank=3

Recruiting

China

This study was undertaken to report the efficacy and safety of dexamethasone combined with rituximab, cyclosporin and intravenous immunoglobulin in the management of newly diagnosed ITP patients. dexamethasone is an agonist of the glucocorticoid receptor the results in the reduction of immune response.

China

https://clinicaltrials.gov/ct2/show/NCT02834468?recrs=a&cond=ITP&draw=1&rank=9

Recruiting

China

Immature platelets—also termed reticulated platelets (RP)—are platelets newly released into the circulation, and have been associated with a variety of pathological bleeding events including primary immune thrombocytopenia (ITP). The diagnosis of primary ITP is based on differential diagnosis and the measurement of RP% can serve as an alternative diagnostic test that are useful in daily practice. This study aims at distinguishing primary ITP from other thrombocytopenic disorders, especially aplastic (hypoplastic) or chemotherapy-induced thrombocytopenia by flow cytometry.

China

https://clinicaltrials.gov/ct2/show/NCT02967328?recrs=a&cond=ITP&draw=2&rank=12

Recruiting

China

Loss of immune tolerance leading to increased platelet destruction and decreased platelet production is the main pathogenesis of ITP. Dysbiosis of the gut microbiota was found as a main influencer in many autoimmune diseases. One ITP patient also diagnosed with ulcerative colitis(UC) was treated with FMT and got progressive but significant increase in platelet level and lasted for several years. This study is examining if gut microbiota plays a bigger role in ITP then previously identified.

China

https://clinicaltrials.gov/ct2/show/NCT03033199?cond=ITP&cntry=CN&rank=32

Recruiting

China

This is a multisite, double-blind, randomized, placebo-controlled, and parallel study designed to evaluate the clinical efficacy and safety of Huaiqihuang granule for treatment to children with chronic primary immune thrombocytopenia. Huaiqihuang granule, a Chinese herbal medicine, has been found to increase nephrin and podocin production which leads to an increase in kidney function.

China

https://clinicaltrials.gov/ct2/show/NCT03201848?recrs=a&cond=ITP&draw=1&rank=25

Recruiting

China

Randomized, open-label, multicentre study to assess the efficacy and safety of the combination of low-dose rituximab and ATRA (All-trans retinoic acid) in patients with steroid-resistant/relapsed ITP.

China

https://clinicaltrials.gov/ct2/show/NCT03304288?cond=itp&cntry=CN&draw=2&rank=47

Recruiting

China

Oseltamivir is a neuraminidase inhibitor, serving as a competitive inhibitor of the activity of the viral neuraminidase (NA) enzyme upon sialic acid, found on glycoproteins on the surface of platelets. By blocking the activity of the enzyme, oseltamivir may prevent platelet destruction in liver. This study hopes to see patients treated with Oseltamivir express elevated platelet levels.

China

https://clinicaltrials.gov/ct2/show/NCT01965626?recrs=a&cond=ITP&draw=2&rank=31

Recruiting

China

This study use a single-center, randomized, open, three-cycle, self-control trial design utilizing the drug Hetrombopag olamine, a non-peptide thrombopoietin (TPO) receptor agonist that attempts to increase platelet production.

China

https://clinicaltrials.gov/ct2/show/NCT03603132?cond=ITP&cntry=CN&rank=46

Recruiting

Columbia

Primary immune thrombocytopenia (ITP) is an uncommon disease characterised by a low platelet count, which may cause the patient to have a higher risk or increased duration of bleeding. By creating this disease registry, this study will be able to build a more complete picture of ITP, including treatment practices, through collecting information about the condition from patients across several hospitals in several countries.

Australia, Colombia, Republic of Korea, Kuwait, Malaysia, Singapore, Taiwan, Thailand, Turkey, Uruguay

https://clinicaltrials.gov/ct2/show/NCT01970189?recrs=a&cond=ITP&draw=4&rank=29

Recruiting

Czechia

Principia Biopharma is conducting a study of their oral drug PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options and have a platelet count <30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment begins. Preclinical findings show that PRN1008 decreases the activity of B cells and other inflammatory-causing immune cells, and in a mouse model of ITP show that PRN1008 can reduce platelet loss.

USA, Bulgaria, Czech Republic, and United Kingdom

https://clinicaltrials.gov/ct2/show/NCT03395210?term=PRN1008&rank=1

Recruiting

 

Czechia

This Phase 2 trial is underway to determine the safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in patients with primary immune thrombocytopenia. The primary focus of this study is to determine if this treatment lowers incidence and severity of serious adverse events. ARGX-113, Efgartigimod, works by degrading circulating disease-causing autoimmune antibodies.

United Kingdom, Austria, Belgium, France, Germany, Hungary, Poland, Spain, Ukraine, Czechia

https://clinicaltrials.gov/ct2/show/NCT03102593?term=ARGX-113&recrs=a&rank=2

Recruiting

Czechia

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia. UCB7665, Rozanolixizumab, works by binding with high-affinity to human neonatal Fc receptor (FcRn), selectively inhibiting IgG rescue and recycling.

Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Italy, Lithuania, Republic of Moldova, Poland, Romania, Spain, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02718716?recrs=a&cond=ITP&draw=1&rank=33

Recruiting

Denmark

Thrombopoietin Receptor Agonists (TPO-RA) are novel treatment modalities for patients with refractory Primary Immune Thrombocytopenia (ITP), but only few data are available for long-term effects of these drugs. In this observational study, long-term effects and adverse effects including evaluation of bone marrow biopsies done at fixed intervals will be recorded from ITP patients treated with TPO-RA.

Denmark

https://clinicaltrials.gov/ct2/show/NCT01443351?recrs=a&cond=ITP&draw=1&rank=8

Recruiting

Egypt

This study investigates eltronmobag as an alternative treatment pathway, which depend on stimulation of thrombocyte synthesis, in chronic and persistent immune thrombocytopenia that may be a more promising treatment than the classic type, not only by increasing platelets count but also through enhancing of the platelets activation and up regulation of GPVI expression on platelet surface.

Egypt

https://clinicaltrials.gov/ct2/show/NCT03412188?recrs=a&cond=ITP&draw=1&rank=13

Recruiting

France

TPO-RAs have been thought to play only a supporting role in ITP management. The purpose of this study is to demonstrate that a substantial proportion of ITP patients may achieve a prolonged response after TPO-RA discontinuation.

France

https://clinicaltrials.gov/ct2/show/NCT03119974?recrs=a&cond=ITP&rank=1

Recruiting

France

Monocytes/macrophages play a double role by phagocyting platelets recognized by autoantibodies and by maintaining the autoimmune response via their antigen-presenting cell functions. Fcgamma receptors (FcγR), that are represented by activating receptors (FcγRI, FcγRIIa, FcγRIII) and an inhibiting one (FcγRIIb), are involved in the regulation of macrophages and have been reported to be dysregulated in autoimmune diseases such as rheumatoid arthritis and systemic lupus erythematous.

The aim of this study is to compare the expression of FcγR in patients with ITP on circulating monocytes and on splenic macrophages.

France

https://clinicaltrials.gov/ct2/show/NCT02821572?recrs=a&cond=ITP&rank=4

Recruiting

France

This study plans to examine the quality of life of patient with chronic idiopathic thrombocytopenic purpura according to the type of treatment received.

France

https://clinicaltrials.gov/ct2/show/NCT03123497?recrs=a&cond=ITP&draw=2&rank=11

Recruiting

France

The influence of ITP on pregnancy (risk of obstetric complications) and on newborns (risk of neonatal thrombocytopenia) is rather unknown and never studied in a prospective study. This study better inform patients affected by ITP and help define better in this context the strategy of supervision of the mother, the fetus and the newborn.
The conclusions of this study will allow us to adapt national guidelines for ITP during pregnancy.

France

https://clinicaltrials.gov/ct2/show/NCT02892630?recrs=a&cond=ITP&draw=4&rank=26

Recruiting

France

Protalex, Inc., a clinical-stage biopharmaceutical company, is now enrolling patients in a Phase I/II open-label, dose-escalating study of PRTX-100 in adults with persistent/chronic ITP. Pre-clinical data indicate that PRTX-100 may have the potential to treat ITP by reducing the immune-mediated destruction of the platelets.

France, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02566603?recrs=a&cond=ITP&draw=1&rank=5

Recruiting

France

Primary immune thrombocytopenia (ITP) is rare. First-line treatment is corticotherapy. Then, several second-line treatments (SLT) are available: splenectomy, off-label rituximab and thrombopoietin-receptor agonists since 2009. The compared efficacy and safety on clinical events in the long-term are unknown. The main objective of the FAITH study is to build the cohort of all treated adult persistent (≥3 months) primary ITP patients in France, to assess the benefit-to-risk ratio of SLT in real-life practice.

France

https://clinicaltrials.gov/ct2/show/NCT03429660?recrs=a&cond=ITP&draw=1&rank=35

Recruiting

France

CARMEN is a clinical registry of all incident adult Immune thrombocytopenia (ITP) and Autoimmune Hemolytic anemia (AIHA) patients in the Midi-Pyrenees region (South of France). It is aimed at describing ITP and AIHA clinical features, assessing the risk-benefit ratio of second-line treatments (SLTs) and adherence to guidelines for ITP and AIHA management.

France

https://clinicaltrials.gov/ct2/show/NCT02877706?recrs=a&cond=ITP&draw=1&rank=38

Recruiting

France

TRANSREG will assess the safety and biological efficacy of low-dose IL2 as a Treg inducer in a set of 14 autoimmune and auto-inflammatory diseases, with the aim to select diseases in which further therapeutic development will be performed. IL2 is a cytokine signaling molecule that can limit immune suppression.

France

https://clinicaltrials.gov/ct2/show/NCT01988506?recrs=a&cond=ITP&draw=2&rank=41

Recruiting

France

This Phase 2 trial is underway to determine the safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in patients with primary immune thrombocytopenia. The primary focus of this study is to determine if this treatment lowers incidence and severity of serious adverse events. ARGX-113, Efgartigimod, works by degrading circulating disease-causing autoimmune antibodies.

United Kingdom, Austria, Belgium, France, Germany, Hungary, Poland, Spain, Ukraine, Czechia

https://clinicaltrials.gov/ct2/show/NCT03102593?term=ARGX-113&recrs=a&rank=2

Recruiting

Georgia

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia. UCB7665, Rozanolixizumab, works by binding with high-affinity to human neonatal Fc receptor (FcRn), selectively inhibiting IgG rescue and recycling.

Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Italy, Lithuania, Republic of Moldova, Poland, Romania, Spain, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02718716?recrs=a&cond=ITP&draw=1&rank=33

Recruiting

Germany

This Phase 2 trial is underway to determine the safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in patients with primary immune thrombocytopenia. The primary focus of this study is to determine if this treatment lowers incidence and severity of serious adverse events. ARGX-113, Efgartigimod, works by degrading circulating disease-causing autoimmune antibodies.

United Kingdom, Austria, Belgium, France, Germany, Hungary, Poland, Spain, Ukraine, Czechia

https://clinicaltrials.gov/ct2/show/NCT03102593?term=ARGX-113&recrs=a&rank=2

Recruiting

Germany

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia. UCB7665, Rozanolixizumab, works by binding with high-affinity to human neonatal Fc receptor (FcRn), selectively inhibiting IgG rescue and recycling.

Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Italy, Lithuania, Republic of Moldova, Poland, Romania, Spain, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02718716?recrs=a&cond=ITP&draw=1&rank=33

Recruiting

Hungary

This Phase 2 trial is underway to determine the safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in patients with primary immune thrombocytopenia. The primary focus of this study is to determine if this treatment lowers incidence and severity of serious adverse events. ARGX-113, Efgartigimod, works by degrading circulating disease-causing autoimmune antibodies.

United Kingdom, Austria, Belgium, France, Germany, Hungary, Poland, Spain, Ukraine, Czechia

https://clinicaltrials.gov/ct2/show/NCT03102593?term=ARGX-113&recrs=a&rank=2

Recruiting

Italy

The primary objective of the study is the evaluation of sustained response rate after discontinuation of treatment with TPO-RAs, Eltrombopag and Romiplostim, in persistent or chronic pITP patients who failed one or more therapy lines, splenectomy included. Increasing evidence exists in the literature on the persistent response after TPO-RAs discontinuation.

Italy

https://clinicaltrials.gov/ct2/show/NCT02298075?recrs=a&cond=ITP&draw=1&rank=23

Recruiting

Italy

This study aims at analyzing the therapeutic activity of TPO-mimetics Eltrombopag and Romiplostim as bridge therapy for splenectomy in adult patients with primary immune thrombocytopenia.

Italy

https://clinicaltrials.gov/ct2/show/NCT02063763?recrs=a&cond=ITP&draw=1&rank=36

Recruiting

Italy

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia. UCB7665, Rozanolixizumab, works by binding with high-affinity to human neonatal Fc receptor (FcRn), selectively inhibiting IgG rescue and recycling.

Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Italy, Lithuania, Republic of Moldova, Poland, Romania, Spain, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02718716?recrs=a&cond=ITP&draw=1&rank=33

Recruiting

Kuwait

Primary immune thrombocytopenia (ITP) is an uncommon disease characterised by a low platelet count, which may cause the patient to have a higher risk or increased duration of bleeding. By creating this disease registry, this study will be able to build a more complete picture of ITP, including treatment practices, through collecting information about the condition from patients across several hospitals in several countries.

Australia, Colombia, Republic of Korea, Kuwait, Malaysia, Singapore, Taiwan, Thailand, Turkey, Uruguay

https://clinicaltrials.gov/ct2/show/NCT01970189?recrs=a&cond=ITP&draw=4&rank=29

Recruiting

Lithuania

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia. UCB7665, Rozanolixizumab, works by binding with high-affinity to human neonatal Fc receptor (FcRn), selectively inhibiting IgG rescue and recycling.

Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Italy, Lithuania, Republic of Moldova, Poland, Romania, Spain, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02718716?recrs=a&cond=ITP&draw=1&rank=33

Recruiting

Malaysia

Primary immune thrombocytopenia (ITP) is an uncommon disease characterised by a low platelet count, which may cause the patient to have a higher risk or increased duration of bleeding. By creating this disease registry, this study will be able to build a more complete picture of ITP, including treatment practices, through collecting information about the condition from patients across several hospitals in several countries.

Australia, Colombia, Republic of Korea, Kuwait, Malaysia, Singapore, Taiwan, Thailand, Turkey, Uruguay

https://clinicaltrials.gov/ct2/show/NCT01970189?recrs=a&cond=ITP&draw=4&rank=29

Recruiting

Poland

This Phase 2 trial is underway to determine the safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in patients with primary immune thrombocytopenia. The primary focus of this study is to determine if this treatment lowers incidence and severity of serious adverse events. ARGX-113, Efgartigimod, works by degrading circulating disease-causing autoimmune antibodies.

United Kingdom, Austria, Belgium, France, Germany, Hungary, Poland, Spain, Ukraine, Czechia

https://clinicaltrials.gov/ct2/show/NCT03102593?term=ARGX-113&recrs=a&rank=2

Recruiting

Poland

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia. UCB7665, Rozanolixizumab, works by binding with high-affinity to human neonatal Fc receptor (FcRn), selectively inhibiting IgG rescue and recycling.

Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Italy, Lithuania, Republic of Moldova, Poland, Romania, Spain, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02718716?recrs=a&cond=ITP&draw=1&rank=33

Recruiting

Republic of Korea

Primary immune thrombocytopenia (ITP) is an uncommon disease characterised by a low platelet count, which may cause the patient to have a higher risk or increased duration of bleeding. By creating this disease registry, this study will be able to build a more complete picture of ITP, including treatment practices, through collecting information about the condition from patients across several hospitals in several countries.

Australia, Colombia, Republic of Korea, Kuwait, Malaysia, Singapore, Taiwan, Thailand, Turkey, Uruguay

https://clinicaltrials.gov/ct2/show/NCT01970189?recrs=a&cond=ITP&draw=4&rank=29

Recruiting

Republic of Moldova

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia. UCB7665, Rozanolixizumab, works by binding with high-affinity to human neonatal Fc receptor (FcRn), selectively inhibiting IgG rescue and recycling.

Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Italy, Lithuania, Republic of Moldova, Poland, Romania, Spain, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02718716?recrs=a&cond=ITP&draw=1&rank=33

Recruiting

Romania

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia. UCB7665, Rozanolixizumab, works by binding with high-affinity to human neonatal Fc receptor (FcRn), selectively inhibiting IgG rescue and recycling.

Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Italy, Lithuania, Republic of Moldova, Poland, Romania, Spain, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02718716?recrs=a&cond=ITP&draw=1&rank=33

Recruiting

Singapore

Primary immune thrombocytopenia (ITP) is an uncommon disease characterised by a low platelet count, which may cause the patient to have a higher risk or increased duration of bleeding. By creating this disease registry, this study will be able to build a more complete picture of ITP, including treatment practices, through collecting information about the condition from patients across several hospitals in several countries.

Australia, Colombia, Republic of Korea, Kuwait, Malaysia, Singapore, Taiwan, Thailand, Turkey, Uruguay

https://clinicaltrials.gov/ct2/show/NCT01970189?recrs=a&cond=ITP&draw=4&rank=29

Recruiting

Spain

Current diagnostic criteria for Immune ThrombocytoPenia (ITP) are mainly based on the presence of low numbers of platelets, excluding other multiple causes of thrombocytopenia, including immunodeficiencies, constitutional or acquired thrombocytopenia, hypersplenism and clonal hematological disorders such as MDS, disorders lymphoproliferative and acute myeloid leukemia (AML), among others. The analysis complementary tests for the diagnosis of ITP include studies basic systematic hematology, together with autoimmune assays and microbiological tests, while the evaluation of bone marrow is limited to elderly patients and/or patients resistant to treatment. In the present study it is planned a broad characterization immunophenotyping of multiple compartments of bone marrow cells and PB platelets from patients with recently diagnosed ITP and investigate their morphological antecedents, in order to identify those patients who show compatible clonal hematopoietic patterns with MDS evident (or at risk of development), as candidates to receive most appropriate therapeutic methods.

Spain

https://clinicaltrials.gov/ct2/show/NCT03469661?recrs=a&cond=ITP&draw=1&rank=15

Recruiting

Spain

This Phase 2 trial is underway to determine the safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in patients with primary immune thrombocytopenia. The primary focus of this study is to determine if this treatment lowers incidence and severity of serious adverse events. ARGX-113, Efgartigimod, works by degrading circulating disease-causing autoimmune antibodies.

United Kingdom, Austria, Belgium, France, Germany, Hungary, Poland, Spain, Ukraine, Czechia

https://clinicaltrials.gov/ct2/show/NCT03102593?term=ARGX-113&recrs=a&rank=2

Recruiting

Spain

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia. UCB7665, Rozanolixizumab, works by binding with high-affinity to human neonatal Fc receptor (FcRn), selectively inhibiting IgG rescue and recycling.

Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Italy, Lithuania, Republic of Moldova, Poland, Romania, Spain, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02718716?recrs=a&cond=ITP&draw=1&rank=33

Recruiting

Switzerland

The study aims to investigate immunomodulatory effects of Thrombopoietin-Receptor Agonist (TPO-RA) in patients with primary ITP, who failed first-line therapy or who became intolerant to it. It is hypothesized that the early phase of this autoimmune disease may exhibit a stronger immunomodulatory potential in response to a stimulus, such as romiplostim. This study examines if such a process may subsequently be capable to induce regulatory mechanisms or tolerance.

Switzerland

https://clinicaltrials.gov/ct2/show/NCT02760251?recrs=a&cond=ITP&draw=1&rank=7

Recruiting

Taiwan

Primary immune thrombocytopenia (ITP) is an uncommon disease characterised by a low platelet count, which may cause the patient to have a higher risk or increased duration of bleeding. By creating this disease registry, this study will be able to build a more complete picture of ITP, including treatment practices, through collecting information about the condition from patients across several hospitals in several countries.

Australia, Colombia, Republic of Korea, Kuwait, Malaysia, Singapore, Taiwan, Thailand, Turkey, Uruguay

https://clinicaltrials.gov/ct2/show/NCT01970189?recrs=a&cond=ITP&draw=4&rank=29

Recruiting

Thailand

Primary immune thrombocytopenia (ITP) is an uncommon disease characterised by a low platelet count, which may cause the patient to have a higher risk or increased duration of bleeding. By creating this disease registry, this study will be able to build a more complete picture of ITP, including treatment practices, through collecting information about the condition from patients across several hospitals in several countries.

Australia, Colombia, Republic of Korea, Kuwait, Malaysia, Singapore, Taiwan, Thailand, Turkey, Uruguay

https://clinicaltrials.gov/ct2/show/NCT01970189?recrs=a&cond=ITP&draw=4&rank=29

Recruiting

Turkey

Primary immune thrombocytopenia (ITP) is an uncommon disease characterised by a low platelet count, which may cause the patient to have a higher risk or increased duration of bleeding. By creating this disease registry, this study will be able to build a more complete picture of ITP, including treatment practices, through collecting information about the condition from patients across several hospitals in several countries.

Australia, Colombia, Republic of Korea, Kuwait, Malaysia, Singapore, Taiwan, Thailand, Turkey, Uruguay

https://clinicaltrials.gov/ct2/show/NCT01970189?recrs=a&cond=ITP&draw=4&rank=29

Recruiting

Ukraine

This Phase 2 trial is underway to determine the safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in patients with primary immune thrombocytopenia. The primary focus of this study is to determine if this treatment lowers incidence and severity of serious adverse events. ARGX-113, Efgartigimod, works by degrading circulating disease-causing autoimmune antibodies.

United Kingdom, Austria, Belgium, France, Germany, Hungary, Poland, Spain, Ukraine, Czechia

https://clinicaltrials.gov/ct2/show/NCT03102593?term=ARGX-113&recrs=a&rank=2

Recruiting

United Kingdom

Principia Biopharma is conducting a study of their oral drug PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options and have a platelet count <30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment begins. Preclinical findings show that PRN1008 decreases the activity of B cells and other inflammatory-causing immune cells, and in a mouse model of ITP show that PRN1008 can reduce platelet loss.

USA, Bulgaria, Czech Republic, and United Kingdom

https://clinicaltrials.gov/ct2/show/NCT03395210?term=PRN1008&rank=1

Recruiting

 

United Kingdom

Protalex, Inc., a clinical-stage biopharmaceutical company, is now enrolling patients in a Phase I/II open-label, dose-escalating study of PRTX-100 in adults with persistent/chronic ITP. Pre-clinical data indicate that PRTX-100 may have the potential to treat ITP by reducing the immune-mediated destruction of the platelets.

USA, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02401061

Recruiting

United Kingdom

Protalex, Inc., a clinical-stage biopharmaceutical company, is now enrolling patients in a Phase I/II open-label, dose-escalating study of PRTX-100 in adults with persistent/chronic ITP. Pre-clinical data indicate that PRTX-100 may have the potential to treat ITP by reducing the immune-mediated destruction of the platelets.

France, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02566603?recrs=a&cond=ITP&draw=1&rank=5

Recruiting

United Kingdom

This is a study of two treatment pathways [Standard steroid treatment versus combined steroid and Mycophenolate (MMF)] for subjects with newly diagnosed Immune Thrombocytopenia (ITP). This study examines if it would benefit more patients if everyone takes MMF at diagnosis instead of current practice (waiting for the illness to come back).

United Kingdom

https://clinicaltrials.gov/ct2/show/NCT03156452?recrs=a&cond=ITP&draw=4&rank=27

Recruiting

United Kingdom

This Phase 2 trial is underway to determine the safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in patients with primary immune thrombocytopenia. The primary focus of this study is to determine if this treatment lowers incidence and severity of serious adverse events. ARGX-113, Efgartigimod, works by degrading circulating disease-causing autoimmune antibodies.

United Kingdom, Austria, Belgium, France, Germany, Hungary, Poland, Spain, Ukraine, Czechia

https://clinicaltrials.gov/ct2/show/NCT03102593?term=ARGX-113&recrs=a&rank=2

Recruiting

United Kingdom

The primary objective of the study is to check if an subcutaneous (sc) infusion of UCB7665 is safe and tolerated in subjects with primary immune thrombocytopenia. UCB7665, Rozanolixizumab, works by binding with high-affinity to human neonatal Fc receptor (FcRn), selectively inhibiting IgG rescue and recycling.

Australia, Belgium, Bulgaria, Czechia, Georgia, Germany, Italy, Lithuania, Republic of Moldova, Poland, Romania, Spain, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02718716?recrs=a&cond=ITP&draw=1&rank=33

Recruiting

United States

Principia Biopharma is conducting a study of their oral drug PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options and have a platelet count <30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment begins. Preclinical findings show that PRN1008 decreases the activity of B cells and other inflammatory-causing immune cells, and in a mouse model of ITP show that PRN1008 can reduce platelet loss.

USA

https://clinicaltrials.gov/ct2/show/NCT03395210?term=PRN1008&rank=1

Recruiting

United States

Protalex, Inc., a clinical-stage biopharmaceutical company, is now enrolling patients in a Phase I/II open-label, dose-escalating study of PRTX-100 in adults with persistent/chronic ITP. Pre-clinical data indicate that PRTX-100 may have the potential to treat ITP by reducing the immune-mediated destruction of the platelets.

USA, United Kingdom

https://clinicaltrials.gov/ct2/show/NCT02401061

Recruiting

United States

The purpose of this study is to explore the safety, preliminary clinical benefit, and activity of BIVV009 in patients with chronic immune thrombocytopenia. BIVV009 has been designed to block the pathway that triggers the immune system to remove damaged cells. It is believed that this approach may limit the number of cells immune system removes and allow the extra cells to help promote platelet production.

USA

https://clinicaltrials.gov/ct2/show/NCT03275454?recrs=a&cond=ITP&draw=4&rank=30

Recruiting

United States

This trial is a Phase 3b open-label, multicenter study to evaluate the safety and efficacy of avatrombopag in subjects with thrombocytopenia scheduled for operations to critical sites or operations with a high risk of bleeding. Avatrombopag has been found to temporarily and safely elevate platelet count.

USA

https://clinicaltrials.gov/ct2/show/NCT03326843?recrs=a&cond=ITP&draw=5&rank=40

Recruiting

United States

Idiopathic thrombocytopenia purpura (ITP) is the destruction of platelets in the body. Autoimmune hemolytic anemia (AIHA) is a rare disease characterized by the body’s premature destruction of red blood cells (hemolysis). Both of these conditions are autoimmune disorders, which means that the body’s immune system malfunctions and attacks healthy blood cells. These two disorders can occur at the same time (destruction of both red blood cells and platelets) or one disorder develops after the other. Evans syndrome is the combination of AIHA with ITP. The cause of Evans syndrome is currently unknown.

A Phase 2 clinical study of an investigational drug is seeking AIHA patients who meet certain criteria.

USA, Canada

https://clinicaltrials.gov/ct2/show/study/NCT02612558

Recruiting

Uruguay

Primary immune thrombocytopenia (ITP) is an uncommon disease characterised by a low platelet count, which may cause the patient to have a higher risk or increased duration of bleeding. By creating this disease registry, this study will be able to build a more complete picture of ITP, including treatment practices, through collecting information about the condition from patients across several hospitals in several countries.

Australia, Colombia, Republic of Korea, Kuwait, Malaysia, Singapore, Taiwan, Thailand, Turkey, Uruguay

https://clinicaltrials.gov/ct2/show/NCT01970189?recrs=a&cond=ITP&draw=4&rank=29

Recruiting