Clinical trials: Primary Immune Thrombocytopenia
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 (ITP)
Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)
The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in patients with immune thrombocytopenia.
- Trial name
- NCT02868060
- Testing
- Romiplostim
- Where
- 5 sites in China
- Volunteers
- 16 people
- Sponsor
- Kyowa Kirin China Pharmaceutical Co., Ltd.
Primary Immune Thrombocytopenia
A Study to Assess the Efficacy, Safety, and Tolerability of Rozanolixizumab in Adult Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
The purpose of this study is to demonstrate the clinical efficacy of rozanolixizumab in maintenance treatment and assess safety and tolerability of rozanolixizumab in adult study participants with primary immune thrombocytopenia…
- Trial name
- myOpportunITy2 (NCT04224688)
- Testing
- Rozanolixizumab
- Where
- 29 sites in United States, Bulgaria and 9 more
- Volunteers
- 30 people
- Sponsor
- UCB Biopharma SRL
Primary Immune Thrombocytopenia
A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia
The main aim of the study is to evaluate the safety and efficacy of efgartigimod PH20 SC (subcutaneous) in adult patients with primary immune thrombocytopenia (ITP).
- Trial name
- ADVANCE SC+ (NCT04812925)
- Testing
- efgartigimod PH20 SC
- Where
- 83 sites in United States, Argentina and 23 more
- Volunteers
- 173 people
- Sponsor
- argenx
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
Primary Immune Thrombocytopenia
Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia
This is a Phase 2, open-label, multicenter, multiple subcutaneous injection, safety and efficacy study of PF-06835375 in adult participants with primary immune thrombocytopenia (ITP).
- Trial name
- NCT05070845
- Testing
- PF-06835375
- Where
- 24 sites in United States, Australia and 5 more
- Volunteers
- 61 people
- Sponsor
- Pfizer
Chronic Thrombocytopenia, Immune Thrombocytopenia
Efficacy and Safety of Oral E5501 Plus Standard of Care for the Treatment of Thrombocytopenia in Adults With Chronic Immune Thrombocytopenia (Amendment 02)
Core Study: To demonstrate that the efficacy of avatrombopag (in addition to standard of care) is superior to placebo (in addition to standard of care) for the treatment of adult participants with chronic immune thrombocytopenia…
- Trial name
- NCT01438840
- Testing
- Avatrombopag, Standard of care
- Where
- 25 sites in Australia, Belgium and 9 more
- Volunteers
- 49 people
- Sponsor
- Eisai Inc.
Idiopathic Thrombocytopenic Purpura
A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura)
Core study: To compare the efficacy of avatrombopag (in addition to standard) of care to eltrombopag (in addition to standard of care) for the treatment of adult participants with chronic immune thrombocytopenia (idiopathic…
- Trial name
- NCT01433978
- Testing
- Eltrombopag, Avatrombopag, Standard of care
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Eisai Inc.
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
Immune Thrombocytopenia (ITP)
A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)
Primary Objective: To evaluate the effect of BIVV020 on the durability of platelet response in participants with persistent/chronic immune thrombocytopenia (ITP) Secondary Objectives: To assess the safety and tolerability of…
- Trial name
- NCT04669600
- Testing
- SAR445088 (BIVV020)
- Where
- 9 sites in United States, Czechia and 4 more
- Volunteers
- 12 people
- Sponsor
- Bioverativ, a Sanofi company
Immune Thrombocytopenia
Phase I Study of SHR-2173 Injection in Patients With Primary Immune Thrombocytopenia
Evaluate the safety and tolerance of multiple subcutaneous injections of SHR-2173 in ITP patients
- Trial name
- NCT07206758
- Testing
- SHR-2173 Injection
- Where
- China
- Volunteers
- 10 people
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
Primary Immune Thrombocytopenia
Role of Eltrombopag as First Line Therapy in Primary Immune Thrombocytopenia.
This will be a double-blind, placebo-control, randomized clinical trial conducted in the Department of Hematology, DMCH for one year.
- Trial name
- EIT (NCT06531018)
- Testing
- Eltrombopag 25 MG, Prednisolone
- Where
- Bangladesh
- Volunteers
- 100 people
- Sponsor
- Renata PLC
Idiopathic Thrombocytopenic Purpura
Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim
The purpose of this study is to describe the number of months with a platelet response over a 12 month treatment period and to describe ITP remission rates in adults with ITP receiving romiplostim.
- Trial name
- NCT01143038
- Testing
- Romiplostim
- Where
- 48 sites in United States, Australia and 7 more
- Volunteers
- 75 people
- Sponsor
- Amgen
Primary Immune Thrombocytopenia
A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Study Participants With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)
The purpose of this study is to assess the long-term safety, tolerability and clinical efficacy of treatment with rozanolixizumab.
- Trial name
- myOpportunITy3 (NCT04596995)
- Testing
- Rozanolixizumab
- Where
- 27 sites in United States, China and 12 more
- Volunteers
- 43 people
- Sponsor
- UCB Biopharma SRL
Immune Thrombocytopenia
Safety and Efficacy of GL-2045 in Patients With Immune Thrombocytopenia
The goal of this clinical trial is to demonstrate GL-2045 safety and efficacy proof of concept by demonstrating intravenous immunoglobulin (IVig)-like platelet responses in adult patients with Immune Thrombocytopenia (ITP).
- Trial name
- NCT07605845
- Testing
- GL-2045
- Where
- United Kingdom
- Volunteers
- 42 people
- Sponsor
- Gliknik Inc.
Primary Immune Thrombocytopenia
A Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Immune Thrombocytopenia
The study is designed to be a randomized, open, multi-center, phase IIa/IIb seamless adaptive trial. Phase IIa: The study consists of a screening period, a core treatment period, an open label extension period, and a safety…
- Trial name
- NCT05232149
- Testing
- Orelabrutinib( lower dose), Orelabrutinib( higher dose)
- Where
- 9 sites in China
- Volunteers
- 30 people
- Sponsor
- Beijing InnoCare Pharma Tech 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
Primary Immune Thrombocytopenia
A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).
This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in participants with primary ITP.
- Trial name
- ADVANCE (NCT04188379)
- Testing
- efgartigimod
- Where
- 121 sites in United States, Austria and 16 more
- Volunteers
- 131 people
- Sponsor
- argenx
Immune Thrombocytopenia (ITP), ITP
A Phase 1b/2a Study of Budoprutug in Subjects With Immune Thrombocytopenia (ITP)
The main objective is to assess the safety and tolerability of budoprutug in adults with ITP. Pharmacokinetics, pharmacodynamics, and preliminary clinical efficacy will also be assessed.
- Conditions
- Immune Thrombocytopenia (ITP), ITP, Biologics, Monoclonal
- Trial name
- NCT07043946
- Testing
- Budoprutug
- Where
- 20 sites in Bulgaria, Greece and 3 more
- Volunteers
- 24 people
- Sponsor
- Climb Bio, Inc.
Primary Immune Thrombocytopenia, Sjögren's Syndrome
Managed Access Programs for VAY736, Ianalumab
The purpose of this registration is to list Managed Access Programs (MAPs) related to VAY736, ianalumab
- Trial name
- NCT07244289
- Testing
- ianalumab
- Sponsor
- Novartis Pharmaceuticals