Clinical trials: Warm Autoimmune Haemolytic Anaemia
Warm Autoimmune Hemolytic Anemia
Zanubrutinib in the Treatment of Relapsed/Refractory wAIHA
Autoimmune hemolytic anemia (AIHA) is a rare and heterogeneous disorder characterized by the destruction of red blood cells through warm or cold antibodies. Glucocorticoid (combined with rituximab) is the first-line treatment.
- Trial name
- NCT05922839
- Testing
- Zanubrutinib
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Chen Miao
Warm Autoimmune Hemolytic Anemia (wAIHA)
A Study of Efficacy and Safety of Ianalumab in Previously Treated Patients With Warm Autoimmune Hemolytic Anemia
The purpose of this study is to evaluate efficacy and safety of ianalumab compared to placebo in patients with warm autoimmune hemolytic anemia, who failed at least one line of treatment.
- Trial name
- VAYHIA (NCT05648968)
- Testing
- Ianalumab
- Where
- 53 sites in United States, Argentina and 14 more
- Volunteers
- 90 people
- Sponsor
- Novartis Pharmaceuticals
Warm Autoimmune Hemolytic Anemia (wAIHA)
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANX005 in Participants With Warm Autoimmune Hemolytic Anemia (wAIHA)
This study will evaluate the safety and tolerability of ANX005 in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
- Trial name
- NCT04691570
- Testing
- ANX005
- Where
- 4 sites in United States, Australia and 2 more
- Volunteers
- 7 people
- Sponsor
- Annexon, Inc.
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
National Longitudinal Cohort of Hematological Diseases- Autoimmune Hemolytic Anemia
Hematological diseases are disorders of the blood and hematopoietic organs. The current hematological cohorts are mostly based on single-center or multi-center cases, or cohorts with limited sample size in China.
- Conditions
- AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia, Autoimmune Hemolytic Anemia Mixed Type
- Trial name
- NICHE-AIHA (NCT07019038)
- Testing
- A combined retrospective and prospective observational follow-up
- Where
- China
- Volunteers
- 9,999 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Autoimmune Hemolytic Anemia, Autoimmune Hemolytic Anemia and Autoimmune Thrombocytopenia
Single-dose Anti-CD20 Antibody With Bortezomib for Relapsed Refractory Autoimmune Hemolytic Anemia
Patients of relapsed and refractory warm autoimmune hemolytic anemia or EVANS syndrome aged 18 to 80 will be included in this study.
- Trial name
- RRAIHA01 (NCT04083014)
- Testing
- combination of a single dose anti-CD20 antibody and bortezomib
- Where
- China
- Volunteers
- 33 people
- Sponsor
- Peking Union Medical College Hospital
Warm Autoimmune Hemolytic Anemia (wAIHA)
Efficacy, Safety and Pharmacokinetics of Rilzabrutinib in Patients With Warm Autoimmune Hemolytic Anemia (wAIHA)
All participants will receive rilzabrutinib orally. The screening period is up to 28 days, followed by a treatment period of 24 weeks for Part A.
- Trial name
- LUMINA 2 (NCT05002777)
- Testing
- rilzabrutinib
- Where
- 27 sites in United States, Austria and 7 more
- Volunteers
- 22 people
- Sponsor
- Sanofi
Warm Autoimmune Hemolytic Anemia
ALXN1830 in Patients With Warm Autoimmune Hemolytic Anemia
The main objective of the study is to evaluate the safety and efficacy of ALXN1830 compared to placebo in adult participants with warm autoimmune hemolytic anemia (WAIHA).
- Trial name
- NCT04256148
- Testing
- ALXN1830
- Where
- United States
- Sponsor
- Alexion Pharmaceuticals, Inc.
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
Autoimmune Thrombocytopenia, Warm Autoimmune Haemolytic Anaemia
IASO-782 in Autoimmune Hematological Diseases
This study is a randomized, double-blinded, and placebo-controlled phase Ia clinical study in subjects with autoimmune hematological diseases.
- Trial name
- NCT06534021
- Testing
- IASO-782 injection
- Where
- 2 sites in China
- Volunteers
- 16 people
- Sponsor
- Shanghai IASO Biotechnology Co., Ltd
Warm Autoimmune Hemolytic Anemia
A Safety Study of SYNT001 in Participants With Warm Autoimmune Hemolytic Anemia (WAIHA)
This main study objective was to evaluate the safety and tolerability of intravenous (IV) SYNT001 (ALXN1830) in participants with WAIHA.
- Trial name
- NCT03075878
- Testing
- ALXN1830
- Where
- 10 sites in United States, Jordan
- Volunteers
- 8 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Autoimmune Haemolytic Anaemia
A Study to Investigate the Efficacy, Safety, and Pharmacokinetics of Oral Rilzabrutinib Compared With Placebo in Participants 18 Years of Age and Older With Warm Autoimmune Hemolytic Anemia
This is a parallel-group, Phase 3, double-blind, 2-arm study to investigate the efficacy, safety, PK and PD of oral rilzabrutinib in achieving durable Hb response (DHR) compared with placebo in approximately 90 male and female…
- Trial name
- LUMINA 3 (NCT07086976)
- Testing
- rilzabrutinib
- Where
- 105 sites in United States, Argentina and 16 more
- Volunteers
- 90 people
- Sponsor
- Sanofi
Warm Autoimmune Hemolytic Anemia
Sirolimus in the Treatment of Refractory/Relapsed wAIHA
Autoimmune hemolytic anemia (AIHA) is a rare and heterogeneous disorder characterized by the destruction of red blood cells through warm or cold antibodies. Glucocorticoid (combined with rituximab) is the first-line treatment.
- Trial name
- NCT05925023
- Testing
- Sirolimus
- Where
- China
- Volunteers
- 22 people
- Sponsor
- Peking Union Medical College Hospital
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
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
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
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
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