Cold Agglutinin Disease Clinical Trial

Cold Agglutinin Disease Real World Evidence Registry

Summary

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). Among them, a minimum of 30 patients with CAD treated with sutimlimab are expected to take part in the sutimlimab cohort study. Patients with CAD who have been enrolled in previous sutimlimab clinical trials (e.g., BIVV009-01/LTS16214 [NCT02502903,CAD patients], BIVV009-03/EFC16215 [NCT03347396], and BIVV009-04/EFC16216 [NCT03347422]) and who either completed or discontinued the corresponding clinical trial are eligible to participate in the registry.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patient aged ≥18 years
Patient able to understand the purpose of the study and who (or whose legally authorized representative) provided signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations
Patient with a diagnosis of CAD or CAS as per Investigator judgment based on the diagnosis criteria listed in study protocol

Exclusion Criteria:

Patient with mixed warm and cold autoimmune hemolytic anemia, or warm autoimmune hemolytic anemia
Patient actively participating in a CAD or CAS interventional clinical trial. After a patient completes participation in said trial, he/she may be eligible for enrollment in this registry.

Study is for people with:

Cold Agglutinin Disease

Estimated Enrollment:

400

Study ID:

NCT05791708

Recruitment Status:

Recruiting

Sponsor:

Sanofi

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There are 19 Locations for this study

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University of Alabama at Birmingham Site Number : 1230
Birmingham Alabama, 35205, United States
SLO Oncology and Hematology Site Number : 1235
San Luis Obispo California, 93401, United States
Orchard Heathcare Research Inc. Site Number : 1202
Skokie Illinois, 60077, United States
Siouxland Regional Cancer Center dba June E. Nylen Cancer Center Site Number : 1220
Sioux City Iowa, 51101, United States
Reliant Medical Group Site Number : 1205
Worcester Massachusetts, 01608, United States
Northwell Health-Monter Cancer Center-North Shore University Hospital and Steven and Alexandra Cohen Children's Medical Center of New York (Schneider Children's Hospital)-North Shore Long Island Jewis Site Number : 1231
Lake Success New York, 11042, United States
Center for Blood Disorders Site Number : 1214
New York New York, 10021, United States
SUNY Upstate Medical University Site Number : 1221
Syracuse New York, 13210, United States
Brody School of Medicine at East Carolina University Site Number : 1203
Greenville North Carolina, 27834, United States
Hematology Oncology Associates, PC Site Number : 1211
Medford Oregon, 97504, United States
Investigational Site Number : 3101
Salzburg , 5020, Austria
Investigational Site Number : 3214
Angers , 49933, France
Investigational Site Number : 3211
CHALON SUR SAONE Cedex , 71100, France
Investigational Site Number : 3206
Corbeil-Essonnes , 91100, France
Investigational Site Number : 3201
Creteil , 94010, France
Investigational Site Number : 3213
Pau , 64000, France
Investigational Site Number : 3205
Saint Priest En Jarez , 42270, France
Investigational Site Number : 3209
Suresnes , 92150, France
Investigational Site Number : 3405
Terni , 05100, Italy

How clear is this clinincal trial information?

Study is for people with:

Cold Agglutinin Disease

Estimated Enrollment:

400

Study ID:

NCT05791708

Recruitment Status:

Recruiting

Sponsor:


Sanofi

How clear is this clinincal trial information?

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