Clinical trials: Autoimmune Haemolytic Anaemia
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
Autoimmune Haemolytic Anaemia
A Safety and Tolerability Study of BIVV020 in Adults With Cold Agglutinin Disease
Primary Objective: To assess the safety and tolerability in participants with cold agglutinin disease (CAD), after a single dose of intravenous (IV) BIVV020 Secondary Objectives: To assess, in participants with cold agglutinin…
- Trial name
- NCT04269551
- Testing
- BIVV020
- Where
- 10 sites in United States, Germany and 4 more
- Volunteers
- 12 people
- Sponsor
- Bioverativ, a Sanofi company
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.
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 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
Alpha-Thalassemia, Beta-Thalassemia
FLOWER: Following Longitudinal Outcomes With Epidemiology for Rare Diseases
FLOWER is a completely virtual, nationwide, real-world observational study to collect, annotate, standardize, and report clinical data for rare diseases.
- Conditions
- Alpha-Thalassemia, Beta-Thalassemia, Amyloidosis, Amyotrophic Lateral Sclerosis
- Trial name
- NCT06539169
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- xCures
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, Cold Agglutinin Disease
Study to Assess the Safety, Tolerability, Efficacy and PK of APL-2 in Patients With Warm Type Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD)
This study is to assess the safety, tolerability, preliminary efficacy, and pharmacokinetics of APL-2 in subjects with warm Autoimmune Hemolytic Anemia (wAIHA) or Cold Agglutinin Disease (CAD).
- Trial name
- NCT03226678
- Testing
- APL-2
- Where
- 8 sites in United States
- Volunteers
- 24 people
- Sponsor
- Apellis Pharmaceuticals, Inc.
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 (AIHA)
HY001N for Patients With Autoimmune Hemolytic Anemia After Failure ≥3 Lines of Therapy.
The goal of this clinical trial is to learn if HY001N cell injection safety and tolerability in adult patients with autoimmune hemolytic anemia after failure of 3 or more lines of therapy.
- Trial name
- NCT07748533
- Testing
- HY001N Cell Injection
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Juventas Cell Therapy Ltd.
Chronic Immune Thrombocytopenia, Autoimmune Hemolytic Anemia
Study of Zola-cel (BMS-986353), in Participants With Autoimmune Cytopenia (Breakfree-AiCE)
The purpose of this study is to evaluate the safety and efficacy of Zola-cel (BMS-986353), in participants with chronic immune thrombocytopenia (cITP) and autoimmune hemolytic anemia (AIHA).
- Trial name
- NCT07603557
- Testing
- BMS-986353, Fludarabine Phosphate, Cyclophosphamide
- Where
- 8 sites in United States, Denmark and 2 more
- Volunteers
- 52 people
- Sponsor
- Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
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 Hemolytic Anemia
A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia
The purpose of this study is to evaluate the safety and efficacy of parsaclisib administered orally to participants with autoimmune hemolytic anemia (AIHA) who have decreased hemoglobin and evidence of ongoing hemolysis that…
- Trial name
- NCT03538041
- Testing
- Parsaclisib
- Where
- 12 sites in United States, Austria and 2 more
- Volunteers
- 25 people
- Sponsor
- Incyte Corporation
Deep Vein Thrombosis, Atrial Fibrillation
Evaluation of Precision and Accuracy of INR Measurements in a Point of Care Device
Comparison of capillary whole blood INR determined by LumiraDx Instrument to venous plasma INR determined by laboratory reference method (IL ACL ELITE PRO) for method comparison and assessment of accuracy and bias by regression…
- Conditions
- Deep Vein Thrombosis, Atrial Fibrillation, Post-Myocardial Infarction Syndrome, Pulmonary Embolism
- Trial name
- OPTIMAL (NCT03682419)
- Testing
- VKA Patients, Non-VKA Patients
- Where
- 3 sites in United Kingdom
- Volunteers
- 420 people
- Sponsor
- LumiraDx UK Limited