Clinical trials: Warm Autoimmune Hemolytic Anemia
Warm Antibody Autoimmune Hemolytic Anemia
HMPL-523 (Sovleplenib) in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
Phase II Study: To evaluate the safety and preliminary efficacy of HMPL-523 in adult patients with wAIHA. Phase III Study(Part A): Confirmation of Efficacy safety and of HMPL-523 in adult patients with wAIHA.
- Trial name
- wAIHA (NCT05535933)
- Testing
- HMPL-523(300mg PO QD)
- Where
- 39 sites in China
- Volunteers
- 111 people
- Sponsor
- Hutchmed
Anemia, Hemolytic, Autoimmune
Prednisolone +/- Addition of Anti-CD20 Antibody, Rituximab, in Patients With Immune Hemolytic Anemia
The conventional treatment in warm-antibody dependent autoimmune haemolytic anaemia (AIHA) is high-dose glucocorticoid, but in more than half of the patients, haemolytic activity will recur after end of treatment or during the…
- Trial name
- NCT01134432
- Testing
- prednisolone + mabthera, Prednisolone
- Where
- 11 sites in Denmark
- Volunteers
- 65 people
- Sponsor
- Copenhagen University Hospital at Herlev
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
Autoimmune Hemolytic Anemia
Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment
The investigators have demonstrated that the mean percentage of circulating CD8+ regulatory T (CD8 Tregs) cells is significantly higher in patients with warm hemolytic anemia (wAHAI) in remission than in controls and is…
- Trial name
- ANEMIL (NCT02389231)
- Testing
- Interleukine-2
- Where
- France
- Volunteers
- 2 people
- Sponsor
- University Hospital, Bordeaux
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.
Autoimmune Hemolytic Anemia, Chronic Lymphocytic Leukemia
Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia
This phase II trial studies the effect of acalabrutinib in treating autoimmune hemolytic anemia that has come back (relapsed) or has not responded to previous treatment (refractory) in patients with chronic lymphocytic leukemia.
- Conditions
- Autoimmune Hemolytic Anemia, Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma, Warm Antibody Autoimmune Hemolytic Anemia
- Trial name
- NCT04657094
- Testing
- Acalabrutinib
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- City of Hope Medical Center
Autoimmune Hemolytic Anemia
A Single-arm Phase 2 Prospective Clinical Study of Enatumab in the Treatment of Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia
Glucocorticoids are the first-line treatment for wAIHA, but patients are prone to recurrence after dose reduction or discontinuation of glucocorticoids. Birgens et al.
- Trial name
- NCT07190261
- Testing
- enatumab
- Where
- China
- Volunteers
- 3 people
- Sponsor
- Bing Han
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
Warm Autoimmune Hemolytic Anemia
Post-trial Access for Nipocalimab in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)
The purpose of this post-trial access (PTA) program is to provide nipocalimab for the treatment of participants with Warm Autoimmune Hemolytic Anemia (wAIHA) who are experiencing clinical benefit after completing 28-weeks…
- Trial name
- NCT05221619
- Testing
- Nipocalimab
- Sponsor
- Janssen Research & Development, LLC
Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia
An Open-label, Single-arm, Prospective, Multicenter, Phase I/II Clinical Study on the Safety and Efficacy of CD19/BCMA CAR-T Cell Therapy for Relapsed/Refractory Warm Antibody Autoimmune Hemolytic Anemia
This study is an open-label, single-arm, prospective, multicenter, phase I/II clinical trial. It adopts the two-stage optimal design proposed by Bryant and Day to investigate the efficacy, safety, and in vivo pharmacokinetic…
- Trial name
- NCT07324889
- Testing
- CD19/BCMA CAR-T
- Volunteers
- 24 people
- Sponsor
- Yihao Wang
Warm Autoimmune Hemolytic Anemia
Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia
The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).
- Trial name
- ENERGY (NCT04119050)
- Testing
- M281
- Where
- 171 sites in United States, Brazil and 17 more
- Volunteers
- 118 people
- Sponsor
- Janssen Research & Development, LLC
Warm Autoimmune Hemolytic Anemia
Subcutaneous ALXN1830 in Adult Participants With Warm Autoimmune Hemolytic Anemia
This is a Phase 2, multiple ascending, dose-finding, randomized, double-blind, placebo-controlled study to evaluate the efficacy, safety, health-related quality of life, tolerability, pharmacokinetic, pharmacodynamic, and…
- Trial name
- NCT04956276
- Testing
- ALXN1830
- Where
- United States
- Sponsor
- Alexion Pharmaceuticals, Inc.
Anemia, Anemia, Hemolytic
Efficacy and Safety of Levamisole Combined With Standard Prednisolone in Warm Antibody Autoimmune Hemolytic Anemia.
The purpose of this study is to determine whether Levamisole plus prednisone can further improve the efficacy，extend the remission duration and reduce the dosage of prednisone for newly diagnosed warm antibody autoimmune…
- Conditions
- Anemia, Anemia, Hemolytic, Anemia, Hemolytic, Autoimmune, Hemolysis
- Trial name
- NCT01579110
- Testing
- levamisole, Prednisone
- Where
- China
- Volunteers
- 100 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Warm Autoimmune Hemolytic Anemia (wAIHA)
Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia
The purpose of this study is to evaluate the efficacy and safety of parsaclisib compared with placebo in participants with Primary Warm Autoimmune Hemolytic Anemia (wAIHA),
- Trial name
- PATHWAY (NCT05073458)
- Testing
- parsaclisinib
- Where
- 56 sites in United States, Austria and 11 more
- Volunteers
- 13 people
- Sponsor
- Incyte Corporation
Warm Antibody Autoimmune Hemolytic Anemia
A Safety and Efficacy Study of R935788 in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA)
The purpose of this study is to evaluate whether fostamatinib is safe and effective in the treatment of Warm Antibody Autoimmune Hemolytic Anemia (AIHA).
- Trial name
- SOAR (NCT02612558)
- Testing
- Fostamatinib 150 mg bid
- Where
- 36 sites in United States, Canada
- Volunteers
- 26 people
- Sponsor
- Rigel Pharmaceuticals
Warm Antibody Autoimmune Hemolytic Anemia
A Phase 3 Open Label Extension Study of Fostamatinib Disodium in the Treatment of Warm Antibody Autoimmune Hemolytic Anemia
The primary objective of this study is: To evaluate the long-term safety of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
- Trial name
- NCT04138927
- Testing
- Fostamatinib disodium
- Where
- 37 sites in United States, Australia and 16 more
- Volunteers
- 90 people
- Sponsor
- Rigel Pharmaceuticals
Primary Immune Thrombocytopenia, Warm Autoimmune Hemolytic Anemia
Study of Ianalumab in Adults With Primary Immune Thrombocytopenia (ITP) and Warm-antibody Autoimmune Hemolytic Anemia (wAIHA) Who Have Previously Benefited From Ianalumab
This study is intended to explore the efficacy and safety of a second course of ianalumab after experiencing treatment failure in the pivotal Primary Immune Thrombocytopenia (ITP) trials (CVAY736I12301, CVAY736Q12301) and after…
- Trial name
- VAY RE-HIT (NCT07039422)
- Testing
- Ianalumab
- Sponsor
- Novartis Pharmaceuticals
Warm Autoimmune Hemolytic Anemia
To Assess the Efficacy and Safety of RVT-1401 in the Treatment of Warm Autoimmune Hemolytic Anemia (ASCEND-WAIHA).
This is a Phase 2 non-randomized, open-label study to investigate the efficacy, safety and tolerability of RVT-1401 in patients with Warm Autoimmune Hemolytic Anemia.
- Trial name
- ASCEND-WAIHA (NCT04253236)
- Testing
- RVT-1401 680 mg/weekly, RVT-1401 340 mg/weekly
- Where
- 21 sites in United States, Israel and 4 more
- Volunteers
- 5 people
- Sponsor
- Immunovant Sciences GmbH
AIHA - Warm Autoimmune Hemolytic Anemia
Ibrutinib in Steroid Refractory Autoimmune Hemolytic Anemia
This is an open-labeled, single arm, Phase II, two staged study of combination of ibrutinib and rituximab in patients with autoimmune cytopenia and underlying CLL.
- Trial name
- ISRAEL (NCT03827603)
- Testing
- Ibrutinib
- Where
- Russia
- Volunteers
- 50 people
- Sponsor
- Eugene Nikitin
Warm Autoimmune Hemolytic Anemia
Rituximab in Auto-Immune Hemolytic Anemia
The hypothesis based on retrospective data is that, the rate of overall response-rate (PR + CR) at 1 year will be much higher in the rituximab arm (80%) than in the placebo arm (20%).Thirty four patients (17 in each arm) will be…
- Trial name
- RAHIA (NCT01181154)
- Testing
- rituximab (Mabthera®)
- Where
- France
- Volunteers
- 32 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris