Clinical Trials Actively Recruiting Internationally

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

A Study of PRN1008 in Adult Patients With Immune Thrombocytopenic Purpura (ITP)

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, Australia, Bulgaria, Canada, Czech Republic, Netherlands, Norway, and United Kingdom

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

Recruiting

Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP) (PTI Fc)

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

Immune Thrombocytopenia in Pregnancy (TIGRO)

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

French Adult Primary Immune Thrombocytopenia

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

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

Recruiting

Autoimmune Cytopenias : Midi-Pyrenees Registry (CARMEN)

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

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

Recruiting

Induction of Regulatory t Cells by Low Dose il2 in Autoimmune and Inflammatory Diseases (TRANSREG)

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

The International ITP Registry

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

Evaluation of HRQoL in Adult With Immune Thrombocytopenia in China (HRQoL)

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

The Association Between Platelet Reactivity and Bleeding Risk in Adult ITP

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

Multicentre, Randomised Phase III Study of the Efficacy and Safety of Hetrombopag Olamine in Idiopathic Thrombocytopenic Purpura (ITP) Patient

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

RP% Measurement by FCM as a Diagnostic Test for ITP

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

Clinical Trial of Gut Microbiota in the Management of Immune Thrombocytopenia

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

The Efficacy and Safety of Huaiqihuang Granule in Children With Chronic Primary Immune Thrombocytopenia (ITP)

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

Response Rate and Duration After Discontinuation Thrombopoietin Receptor Agonists Primary Immune Thrombocytopenia

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

The Effect of Eltrombopag on the Expression of Platelet Collagen Receptor GPVI in Pediatric ITP

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

Differential Diagnostic of Immune ThrombocytoPenia (ITP) and Myelodysplastic Syndrome (MDS)

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

H. Pylori Eradication for Moderate ITP

The purpose of this study is to determine the efficacy of H. pylori eradication for the treatment of chronic or persistent immune thrombocytopenic purpura (ITP) patients with moderate thrombocytopenia. H. pylori can lead to increased inflammation that can exacerbate ITP symptoms.
This is a multi-center, open label, prospective randomized phase IIl study.

Republic of Korea

https://clinicaltrials.gov/ct2/show/NCT03177629?recrs=a&cond=ITP&draw=1&rank=20

Recruiting

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