Clinical trials: Cold Agglutinin Disease
Cold Agglutinin Disease
A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Without A Recent History of Blood Transfusion
The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (>=)1.5 grams per deciliter (g/dL) increase in hemoglobin (Hgb) level and avoidance of transfusion in participants…
- Trial name
- Cadenza (NCT03347422)
- Testing
- sutimlimab (BIVV009)
- Where
- 53 sites in United States, Australia and 12 more
- Volunteers
- 42 people
- Sponsor
- Bioverativ, a Sanofi company
Cold Agglutinin Disease
Sutimlimab (BIVV009) for the Adult Participants With Cold Agglutinin Disease (CAD) Who Have Completed Phase 3 Studies (CARDINAL or CADENZA) in Japan
This was a multi-center, single treatment-group, open-label study to provide sutimlimab to the adult participants with cold agglutinin disease (CAD) who had completed the CARDINAL (NCT number: NCT03347396) or CADENZA (NCT number…
- Trial name
- NCT05132127
- Testing
- sutimlimab
- Where
- 5 sites in Japan
- Volunteers
- 7 people
- Sponsor
- Sanofi
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
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
Cold Agglutinin Disease, Autoimmune Hemolytic Anemia
Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease
Prospective, non-randomized multicenter study on the safety and efficacy of combination therapy with bendamustine and rituximab for chronic cold agglutinin disease.
- Trial name
- CAD5 (NCT02689986)
- Testing
- Bendamustine, Rituximab
- Where
- 8 sites in Denmark, Finland and 1 more
- Volunteers
- 43 people
- Sponsor
- Helse Fonna
First in Man Study to Evaluate Initial Safety
Safety, Tolerability, Pharmacokinetic, and Pharmacodynamic Study in Healthy Male and Female Subjects and Safety, Tolerability, Pharmacokinetics, and Pilot Efficacy Biomarkers in Subjects With Cold Agglutinin Disease
The purpose of this first-in-human (FIH) study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of GL-0719 following single intravenous (IV) and subcutaneous injection (SC) doses in…
- Trial name
- NCT05318534
- Testing
- GL-0719
- Where
- United Kingdom
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Gliknik Inc.
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.
Cold Agglutinin Disease
A Study to Evaluate the Efficacy and Safety of Pegcetacoplan in Patients With Cold Agglutinin Disease (CAD)
The purpose of the study is to determine the efficacy of pegcetacoplan administration compared to placebo in increasing hemoglobin (Hgb) level from baseline and avoiding transfusion in participants with primary cold agglutinin…
- Trial name
- NCT05096403
- Testing
- Pegcetacoplan
- Where
- 44 sites in United States, Austria and 12 more
- Volunteers
- 24 people
- Sponsor
- Swedish Orphan Biovitrum
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
AIHA - Warm Autoimmune Hemolytic Anemia, AIHA - Cold Autoimmune Hemolytic Anemia
A Multicenter Prospective Study of Iptacopan in the Treatment of Refractory/Relapsed Autoimmune Hemolytic Anemia (AIHA)
To evaluate the efficacy and safety of ipecopam in the treatment of refractory/relapsed AIHA.
- Trial name
- NCT06847607
- Testing
- Iptacopan
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Bing Han
Autoimmune Haemolytic Anaemia
Safety and Tolerability Study in Adults With Cold Agglutinin Disease Previously Treated With SAR445088 or Never Treated With SAR445088
Primary Objective: To assess the long-term safety and tolerability in patients with cold agglutinin disease (CAD), after multiple doses of SAR445088 Secondary Objective: To assess, in patients with cold agglutinin disease (CAD)…
- Trial name
- NCT04802057
- Testing
- SAR445088
- Where
- 5 sites in Germany, Italy and 3 more
- Volunteers
- 9 people
- Sponsor
- Bioverativ, a Sanofi company
Cold Agglutinin Disease (CAD), Cold Agglutinin Syndrome (CAS)
Cold Agglutinin Disease Real World Evidence Registry
This is a multinational, multi-center, observational, prospective, longitudinal disease registry designed to collect data on participants with cold agglutinin disease (CAD) or cold agglutinin syndrome (CAS).
- Trial name
- CADENCE (NCT05791708)
- Testing
- Sutimlimab
- Where
- 68 sites in United States, Austria and 6 more
- Volunteers
- 429 people
- Sponsor
- RECORDATI GROUP
Pemphigus, Auto-immune Thrombocytopenic Purpura
The RITAI Cohort: An Observational Study on Rituximab Off-label Use for Auto-immune Disorders
The primary purpose of the study is to describe by a prospective observational study the serious adverse events occurring in patients treated off-label by rituximab for various auto-immune diseases.
- Conditions
- Pemphigus, Auto-immune Thrombocytopenic Purpura, Hemolytic Auto-immune Anaemia, Cold Agglutinin Disease
- Trial name
- RITAI (NCT00960713)
- Testing
- Rituximab (MABTHERA® or RITUXAN®).
- Where
- France
- Volunteers
- 35 people
- Sponsor
- University Hospital, Toulouse
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
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
Autoimmune Hemolytic Anemia, Immune Thrombocytopenia
Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia
The goal of this observational study is to characterize the diagnostic and therapeutic management of autoimmune cytopenias including autoimmune hemolytic anemia, immune thrombocytopenia, and chronic idiopathic/autoimmune…
- Conditions
- Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, Chronic Idiopathic Neutropenia, Autoimmune Neutropenia
- Trial name
- AIHA ITP CIN (NCT05931718)
- Testing
- cytokine essays, NGS, Fecal microbiome
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
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
Refractory Cold Agglutinin Disease
Short Course of Bortezomib in Anemic Patients With Refractory Cold Agglutinin Disease
This multicenter, phase II, open label study will enroll patients with chronic cold agglutinin disorder. A single course of Bortezomib will be given at the dose of 1,3 mg/sqm iv on days 1, 4, 8, 11.
- Trial name
- CAD0111 (NCT01696474)
- Testing
- Bortezomib
- Where
- 8 sites in Italy
- Volunteers
- 21 people
- Sponsor
- Gruppo Italiano Malattie EMatologiche dell'Adulto
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.
Lymphoma
Zanubrutinib in Primary Cold Agglutinin Disease
Cold agglutinin disease (CAD) is defined as a chronic autoimmune hemolytic anemia (AIHA) with a monospecific direct antiglobulin test (DAT) strongly positive for C3d and the presence of cold agglutinins (CA; titer ≥ 64 at 4°C).
- Trial name
- HOVON169CAD (NCT06067048)
- Testing
- Zanubrutinib Oral Capsule
- Where
- 10 sites in Belgium, Denmark and 2 more
- Volunteers
- 25 people
- Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland