Clinical trials: Primary Immune Thrombocytopenia (ITP)
Drug Effect, Safety Issues
Study of Efficacy, Safety and Immunogenicity of GP40141 (GEROPHARM, Russia) in Patients With Immune Thrombocytopenia
The goal of this clinical trial is to demonstrate equivalent efficacy and comparable safety of the drug GP40141 (GEROPHARM, Russia) in comparison with the drug Nplate® (Amgen, the Netherlands). the main questions are 1.
- Conditions
- Drug Effect, Safety Issues, Immunogenicity
- Trial name
- NCT06497036
- Testing
- GP404141, Nplate
- Where
- 6 sites in Russia
- Volunteers
- 160 people
- Sponsor
- Geropharm
Purpura, Thrombocytopaenic, Idiopathic
Study Of Eltrombopag in Healthy Subjects and Volunteers With Mild, Moderate or Severe Hepatic Impairment
The main purpose of this study is to compare how one 50mg tablet of SB-497115 is broken down in the body by healthy subjects versus subjects with mild, moderate or severe liver problems.
- Trial name
- NCT00359463
- Testing
- eltrombopag
- Where
- 5 sites in United States, Australia and 1 more
- Volunteers
- 33 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Primary Immune Thrombocytopenia
Study of CM313 (SC) Injection in Subjects With Primary Immune Thrombocytopenia (ITP)
This is a randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and initial efficacy of CM313 (SC) injection in patients with primary immune…
- Trial name
- NCT06594146
- Testing
- CM313 injection
- Where
- China
- Volunteers
- 62 people
- Sponsor
- Keymed Biosciences Co.Ltd
Primary Immune Thrombocytopenia
A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With ITP
The purpose of the study is to determine safety, efficacy, tolerability and Pharmacokinetics of ARGX-113 in Patients with Primary Immune Thrombocytopenia.
- Trial name
- NCT03102593
- Testing
- ARGX-113
- Where
- 30 sites in Austria, Belgium and 8 more
- Volunteers
- 38 people
- Sponsor
- argenx
Immune Thrombocytopenia
Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders
This study will evaluate the safety and efficacy of tafasitamab in adult participants with primary autoimmune blood cell disorders.
- Trial name
- NCT07104565
- Testing
- INCA000585
- Where
- 39 sites in United States, Australia and 5 more
- Volunteers
- 56 people
- Sponsor
- Incyte Corporation
Immune Thrombocytopenia
PRTX-100-203 Open-Label, Dose Escalation Study in Adult Patients With ITP
Pre-clinical and clinical evaluations show that PRTX- 100 has biological activity that may lead to improved platelet levels where these are decreased due to immunological pathologies and that PRTX-100 has an acceptable safety…
- Trial name
- NCT02566603
- Testing
- PRTX-100
- Where
- 16 sites in France, United Kingdom
- Volunteers
- 15 people
- Sponsor
- Protalex, Inc.
Immune Thrombocytopenia (ITP)
The Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of HMPL-523 in Immune Thrombocytopenia Patients
This is a randomized, double blinded, placebo-controlled phase Ib clinical trial in adult patients with immune thrombocytopenia. Cross-over treatment will be allowed during the study.
- Trial name
- NCT03951623
- Testing
- HMPL-523
- Where
- China
- Volunteers
- 45 people
- Sponsor
- Hutchison Medipharma Limited
Immune Thrombocytopenia (ITP), Warm Autoimmune Hemolytic Anemia (WAIHA)
A Phase 1b/2a Study of Velinotamig in Adults With Relapsed/Refractory ITP and wAIHA
A Phase 1b/2a, open-label dose escalation and dose expansion study of subcutaneously (SC) administered velinotamig for the treatment of adults with relapsing and refractory immune thrombocytopenia (ITP) and warm autoimmune…
- Trial name
- NCT07738822
- Testing
- Velinotamig specified dose on specified days.
- Where
- United States
- Volunteers
- 72 people
- Sponsor
- Cullinan Therapeutics Inc.
Immune Thrombocytopenia
Study of Oral SKI-O-703, SYK Inhibitor, in Patients With Persistent and Chronic Immune Thrombocytopenia (ITP)
Study in patients with persistent and chronic Immune Thrombocytopenia (ITP), who have failed to respond or relapsed after prior therapy, with a platelet count <30,000/µL.
- Trial name
- NCT04056195
- Testing
- SKI-O-703
- Where
- 27 sites in United States, Greece and 3 more
- Volunteers
- 61 people
- Sponsor
- Oscotec Inc.
Immune Thrombocytopenia
A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)
This was a 2 part (Part A and B) adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count <30,000/μL on two…
- Trial name
- NCT03395210
- Testing
- Rilzabrutinib
- Where
- 31 sites in United States, Australia and 6 more
- Volunteers
- 86 people
- Sponsor
- Principia Biopharma, a Sanofi Company
Primary Immunodeficiency Diseases (PID), Immune Thrombocytopenic Purpura (ITP)
Safety and Efficacy Study of a 10% Intravenous Immune Globulin Solution in Subjects With Primary Immunodeficiency Disorders
The purpose of this study is to assess the safety and efficacy of Immune Globulin Intravenous (Human), 10% (IGIV 10%) in subjects with primary immunodeficiency disorders.
- Conditions
- Primary Immunodeficiency Diseases (PID), Immune Thrombocytopenic Purpura (ITP), Kawasaki Syndrome
- Trial name
- NCT00157079
- Testing
- Immune Globulin Intravenous (Human), 10%
- Where
- 11 sites in United States
- Volunteers
- 61 people
- Sponsor
- Baxalta now part of Shire
Immune Thrombocytopenia
Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)
This was a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of <30,000/μL (and no single platelet count >35,000/μL) on two counts at least 5 days apart in…
- Trial name
- LUNA 3 (NCT04562766)
- Testing
- Rilzabrutinib
- Where
- 155 sites in United States, Argentina and 24 more
- Volunteers
- 232 people
- Sponsor
- Principia Biopharma, a Sanofi Company
Immune Thrombocytopenia, ITP
An Observational, Multicenter Study to Evaluate the Use and Effectiveness of Doptelet® in Patients With ITP
This is a multi-center, observational, Phase 4 study in patients with Immune Thrombocytopenia (ITP) designed to describe the real-world effectiveness of Doptelet and assess the patterns of drug utilization to add to the knowledge…
- Trial name
- ADOPT (NCT04943042)
- Testing
- Avatrombopag
- Where
- 55 sites in Croatia, Czechia and 7 more
- Volunteers
- 199 people
- Sponsor
- Swedish Orphan Biovitrum
Immune Thrombocytopenia
Rilzabrutinib for the Adult Participants With Chronic ITP Who Have Completed Phase 3 Study in Japan
This is an open-label, multi-center, single group, Phase 3 study for treatment with rilzabrutinib. The purpose of this study is to provide continuation of rilzabrutinib treatment to adult participants with ITP who have completed…
- Trial name
- NCT07216079
- Testing
- rilzabrutinib
- Where
- 3 sites in Japan
- Volunteers
- 4 people
- Sponsor
- Sanofi
Immune Thrombocytopenia
This Clinical Study is to Test Efficacy and Safety of BT595 in Chronic Primary Immune Thrombocytopenia (ITP)
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.
- Trial name
- NCT02859909
- Testing
- BT595
- Where
- 22 sites in Bulgaria, Czechia and 4 more
- Volunteers
- 34 people
- Sponsor
- Biotest
Autoimmune Hemolytic Anemia, Immune Thrombocytopenia
A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITP
This is a Phase 2 randomized, dose-blind, multicenter study designed to evaluate the safety, tolerability, efficacy, Pharmacokinetics (PK), and Pharmacodynamics (PD) of treatment with KZR-616 in patients with active Autoimmune…
- Trial name
- MARINA (NCT04039477)
- Testing
- KZR-616
- Where
- 22 sites in United States, Australia and 3 more
- Sponsor
- Kezar Life Sciences, Inc.
Idiopathic Inflammatory Myopathies(IIM), Immune Thrombocytopenia(ITP)
An Exploratory Study of CD19/CD22/BCMA CAR-T Cells (BZE2204) in Subjects With Relapsed or Refractory Autoimmune Diseases
This is a single arm, open-label, dose escalation and expansion study to evaluate the safety, tolerability and preliminary efficacy of autologous chimeric antigen receptor T (CAR-T) cells targeting CD19/CD22/BCMA(BZE2204) in…
- Conditions
- Idiopathic Inflammatory Myopathies(IIM), Immune Thrombocytopenia(ITP), Systemic Lupus Erythematosus(SLE)
- Trial name
- NCT07174843
- Testing
- CD19/CD22/BCMA CAR-T cells(BZE2204)
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Shanghai Cell Therapy Group Co.,Ltd
Chronic Immune Thrombocytopenia, Primary Immune Thrombocytopenia
Cognitive Status, Fatigue and Inflammation in Patients With Immune Thrombocytopenia (ITP)
This is a multi-center, hospital based, cross-sectional study based on data from patient medical records, including laboratory results.
- Conditions
- Chronic Immune Thrombocytopenia, Primary Immune Thrombocytopenia, Adult Immune Thrombocytopenia
- Trial name
- NCT06665308
- Testing
- No intervention
- Where
- 4 sites in United States, United Kingdom
- Volunteers
- 97 people
- Sponsor
- Sanofi
Primary Immune Thrombocytopenia
SG301-SC Injection Safety Study in Subjects With Primary ITP Patients
This is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study. The primary objective is to evaluate the safety and efficacy of SG301 SC Injection in participants with ITP, while the secondary…
- Trial name
- NCT07710248
- Testing
- low dose group, high dose group
- Where
- 22 sites in China
- Volunteers
- 60 people
- Sponsor
- Hangzhou Sumgen Biotech Co., Ltd.
AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia
OM336 in Autoimmune Cytopenias
An early-phase clinical trial evaluating the safety, tolerability, and pharmacokinetics of subcutaneously dosed OM336 in adult participants with autoimmune cytopenias.
- Conditions
- AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia, ITP - Immune Thrombocytopenia
- Trial name
- NCT07083960
- Testing
- OM336
- Where
- 7 sites in United States, Australia
- Volunteers
- 32 people
- Sponsor
- Lakefront Biotherapeutics West LLC