To study the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc)in Haemophilia B patients.

Phase 3

Completed

• Conditions: Haemophilia B

• Registration Number: CTRI/2012/05/002708
• Lead Sponsor: Biogen Idec United Kingdom

Brief Summary

This is an open-label, multicenter, long-term study of intravenous (IV) administration of rFIXFc in previously treated patients with hemophilia B, who completed the B-LONG study (998HB102), the pediatric study (9HB02PED), or any other Phase 3 trial with rFIXFc. Treatment will be administered as prophylactic or on-demand regimens.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-28
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 120

Inclusion Criteria

• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
• Parental or guardian consent is required for subjects who are less than 18 years of age or unable to give consent, or as applicable per local laws.
• Subjects who are less than 18 years of age may provide assent in addition to the parental/guardian consent, if appropriate.
• Subjects who have completed the studies 998HB102, 9HB02PED, or other Phase 3 studies with rFIXFc.

Exclusion Criteria

• Confirmed positive high-titer inhibitor test (≥5.00 BU/mL) 2.
• Medical or other reasons that, in the opinion of the Investigator make the subject unsuitable for enrollment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of the study is to evaluate the long-term safety of rFIXFc in subjects with hemophilia B.	4 years

Secondary Outcome Measures

Name	Time	Method
number of bleeding episodes per subject	Time Frame up to four years

Trial Locations

Locations (3)

Christian Medical College, Vellore; 🇮🇳 Vellore, TAMIL NADU, India

Sahyadari Hospital; 🇮🇳 Pune, MAHARASHTRA, India

St.Johns Hospital Bangalore; 🇮🇳 Bangalore, KARNATAKA, India

Christian Medical College, Vellore

🇮🇳Vellore, TAMIL NADU, India

DrAlok Srivastava

Principal investigator

haemres@cmcvellore.ac.in