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

An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A - A LONG

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/11/002103

Enrollment

150

Registered

2011-11-02

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Severe Haemophilia A

Interventions

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

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: History of Factor VIII inhibitors Kidney and liver dysfunction Diagnosed with other coagulation disorder(s) other than hemophilia A Prior history of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration

Design outcomes

Primary

Measure	Time frame
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 ]	—

Measure

Time frame

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

Measure	Time frame
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 ]	—

Measure

Time frame

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 ]

—

Countries

Australia, Austria, Belgium, Brazil, Canada, Chile, China, France, Germany, Hong Kong, India, Italy, Japan, New Zealand, Poland, Russian Federation, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States of America

Contacts

Public ContactDr Ritika Bajaj

Biogen Idec

anjali.nagpal@biogenidec.com911244572343

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026