Clinical trials: Anemia, Hemolytic, Autoimmune
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
Ultomiris-exposed Pregnant/ Postpartum, Pregnancy
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of…
- Conditions
- Ultomiris-exposed Pregnant/ Postpartum, Pregnancy, Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS)
- Trial name
- NCT06312644
- Testing
- Ultomiris
- Where
- 7 sites in United States, Australia and 5 more
- Volunteers
- 75 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Agglutinin Disease, Cold
A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)
The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increased Hgb to >= 12 g/dL and obviated the…
- Trial name
- NCT03347396
- Testing
- BIVV009
- Where
- 49 sites in United States, Australia and 12 more
- Volunteers
- 24 people
- Sponsor
- Bioverativ, a Sanofi company
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
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.
Immune Thrombocytopenia (ITP), Cold Agglutinin Disease (CAD)
Basket Study to Assess Efficacy, Safety and PK of Iptacopan (LNP023) in Autoimmune Benign Hematological Disorders
The main purpose of this study was to evaluate the efficacy and safety of iptacopan in participants with autoimmune benign hematological disorders such as primary immune thrombocytopenia and primary cold agglutinin disease.
- Trial name
- NCT05086744
- Testing
- Iptacopan
- Where
- 8 sites in United States, Germany and 4 more
- Volunteers
- 19 people
- Sponsor
- Novartis Pharmaceuticals
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
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
IgA Nephropathy, Paroxysmal Nocturnal Hemoglobinuria
A Clinical Study to Evaluate the Effect of Food on the Pharmacokinetic Profiles of HRS-5965 Capsules in Healthy Subjects
The study is being conducted to evaluate the effect of food on pharmacokinetics of HRS-5965 capsules after oral administration.
- Trial name
- NCT07035665
- Testing
- HRS-5965 Capsules
- Where
- China
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Chengdu Suncadia Medicine Co., Ltd.
AIHA - Cold Autoimmune Hemolytic Anemia
Inaticabtagene Autoleucel Injection in the Treatment of Autoimmune Hemolytic Anemia After Three or More Lines of Therapy
This is a multicenter, open-label, single-arm Phase I clinical trial to evaluate the safety and tolerability of Inaticabtagene Autoleucel Injection treatment in autoimmune hemolytic anemia that has failed at least three lines of…
- Trial name
- NCT07091370
- Testing
- Inaticabtagene Autoleucel Injection
- Volunteers
- 12 people
- Sponsor
- Juventas Cell Therapy Ltd.
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.
Warm Autoimmune Hemolytic Anemia
A Study of Obexelimab in Patients With Warm Autoimmune Hemolytic Anemia (SApHiAre)
This study aims to examine the efficacy and safety of obexelimab in participants with Warm Autoimmune Hemolytic Anemia (wAIHA).
- Trial name
- NCT05786573
- Testing
- Obexelimab
- Where
- 7 sites in Italy, Poland and 3 more
- Volunteers
- 134 people
- Sponsor
- Zenas BioPharma (USA), LLC
Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD)
Safety, Tolerability and Activity of BIVV009 in Healthy Volunteers and Patients With Complement Mediated Disorders
Prospective, double-blind, randomized, placebo-controlled First-In-Human study with four sub-parts: Part A, a single ascending dose study (SAD) in normal human volunteers (NHVs), Part B, a multiple ascending dose study (MAD) in…
- Conditions
- Bullous Pemphigoid (BP), Cold Agglutinin Disease (CAD), Warm Autoimmune Hemolytic Anemia (WAIHA), End-stage Renal Disease (ESRD)
- Trial name
- BIVV009-01 (NCT02502903)
- Testing
- BIV009
- Where
- Austria
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Bioverativ, a Sanofi company
Warm Antibody Autoimmune Hemolytic Anemia
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study of Fostamatinib Disodium in the Treatment of wAIHA
The primary objective of this study is to assess the efficacy of fostamatinib in subjects with warm antibody autoimmune hemolytic anemia (wAIHA).
- Trial name
- NCT03764618
- Testing
- Fostamatinib disodium
- Where
- 102 sites in United States, Australia and 20 more
- Volunteers
- 90 people
- Sponsor
- Rigel Pharmaceuticals