Study to Evaluate the Safety, Pharmacokinetics and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in Subjects With Severe Hemophilia A

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2011
INTERVENTION: Intervention1: Arm 1 ‐ Tailored Prophylaxix Regimen: Prophylactic Treatment with rFVIII 20 ‐50 IU/kg. 52 Weeks Intervention2: Arm 2 ‐ Weekly Dosing Regimen: Prophylactic treatment with 65 IU/kg fixed dose, weekly regimen. 52 Weeks Intervention3: Arm 3 ‐ On Demand Regimen: Subjects to be treated with 20 ‐ 50 IU/kg depending upon the severity of the bleed. Patient to treat bleeds as they occur for 52 Weeks. Control Intervention1: Nil: Nil CONDITION: Severe Haemophilia A PRIMARY OUTCOME: Clinically notable changes from baseline in physical examinations, vital signs, lab values, and incidence of AEs and inhibitor development [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ] ; ; Annual number of bleeding episodes (spontaneous and traumatic) [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ] ; ; ; ‐‐‐‐‐‐Timepoint: Clinically notable changes from baseline in physical examinations, vital signs, lab values, and incidence of AEs and inhibitor development [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ] ; ; Annual number of bleeding episodes (spontaneous and traumatic) [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ] ; ; ; SECONDARY OUTCOME: Total annualized rFVIIIFc consumption per subject [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ] ; ; Evaluation of PK parameter estimates of rFVIIIFc and rFVIII [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ] ; ; Evaluation of subjects response to treatment [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ] ; ; To evaluate the efficacy of rFVIIIFc used in a surgical subgroup [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ] ; ; ; ‐‐‐‐‐‐Timepoint: [ Time Frame: 156 weeks ] [ Designated as safety issue: Yes ] INCLUSION CRITERIA: Male, greater than or equal to 12 years of age and weigh at least 40 kg Diagnosed with severe hemophilia A defined as 1 IU/dL (1%) endogenous Factor VIII) History of at least 150 documented prior exposure days to any Factor VIII product Platelet count greater than or equal to 100,000 cells/micro L Note: As per DCGI approval, lower age limit in INDIA is 18 years
Epistemonikos ID: 0f099e15bc44384924abcf76114f1f9efd6a4280
First added on: Aug 22, 2024