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Titre abrégé
BIOVERATIV / BIVV009-04
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NCT
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N° Eudract
2017-003539-12
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Phase de l'essai
- Phase III
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Type de promoteur
Académique / Institutionnel
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Nom du promoteur
Bioverativ Therapeutics
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Inclusion Criteria: Body weight of greater than or equal to (>=) 39 kilogram (kg) at Screening Confirmed diagnosis of primary cold agglutinin disease (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, and e) Immunoglobulin G (IgG) DAT less than or equal to (<=) 1+, and, f) No overt malignant disease Hemoglobin level <= 10.0 gram per deciliter (g/dL) Bilirubin level above the normal reference range, including patients with Gilbert's Syndrome
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Exclusion Criteria: Cold agglutinin syndrome secondary to infection, rheumatologic disease, or active hematologic malignancy Clinically relevant infection of any kind within the month preceding enrollment (example, active hepatitis C, pneumonia) Clinical diagnosis of systemic lupus erythematosus (SLE), or other autoimmune disorders with anti-nuclear antibodies at Screening. Anti-nuclear antibodies of long-standing duration without associated clinical symptoms will be 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 (example, with bendamustine, fludarabine, ibrutinib, or cytotoxic drugs) within 6 months prior to enrollment
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Nom du centre
HCL - CH Lyon Sud
Lyon -
Contact Investigateur
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Nom
Lionel KARLIN
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Contact ARC/TER/IRC
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Nom
Ext-Melanie PESSE