Status:
COMPLETED
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)
Lead Sponsor:
Bioverativ, a Sanofi company
Conditions:
Agglutinin Disease, Cold
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Body weight of \>= 39 kg at screening.
- Confirmed diagnosis of primary CAD based on the following criteria: a) Chronic hemolysis; b) Polyspecific direct antiglobulin test (DAT) positive; c) Monospecific DAT strongly positive for C3d; d) Cold agglutinin titer \>= 64 at 4 degree celsius; e) Immunoglobulin G (IgG) DAT less than or equal to (\<=) 1+, and f) No overt malignant disease.
- History of at least one documented blood transfusion within 6 months of enrollment.
- Hemoglobin level \<= 10.0 g/dL.
- Bilirubin level above the normal reference range, including participants with Gilbert's Syndrome.
Exclusion
- Cold agglutinin syndrome secondary to infection, rheumatologic disease, or active hematologic malignancy.
- Clinically relevant infection of any kind within the month preceding enrollment (e.g., active hepatitis C, pneumonia).
- Clinical diagnosis of systemic lupus erythematosus; or other autoimmune disorders with anti-nuclear antibodies at Screening. Anti-nuclear antibodies of long-standing duration without associated clinical symptoms adjudicated on a case-by-case basis during the Confirmatory Review of Patient Eligibility.
- Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at Screening.
- Positive human immunodeficiency virus (HIV) antibody at screening.
- Treatment with rituximab monotherapy within 3 months or rituximab combination therapies (e.g., with bendamustine, fludarabine, ibrutinib, or cytotoxic drugs) within 6 months prior to enrollment.
Key Trial Info
Start Date :
March 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 5 2021
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03347396
Start Date
March 5 2018
End Date
October 5 2021
Last Update
October 31 2022
Active Locations (49)
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1
Arizona Oncology Associates PC
Tucson, Arizona, United States, 85711
2
USC/Keck School of Medicine
Los Angeles, California, United States, 90033
3
The Oncology Institute of Hope and Innovation
Whittier, California, United States, 90603
4
Georgetown University Medical Center
Georgetown, District of Columbia, United States, 20007