Long-Term Safety and Efficacy of rFIXFc in the Prevention and Treatment of Bleeding Episodes in Previously Treated Participants With Hemophilia B (B-YOND)

Bioverativ

Status and phase: Completed; Phase 3

Conditions: Severe Hemophilia B

Treatments: Biological: rFIXFc

Study type: Interventional

Funder types: Industry

Identifiers

NCT01425723

2011-003075-11

9HB01EXT

Details and patient eligibility

About

The primary objective of the study is to evaluate the long-term safety of rFIXFc in participants with hemophilia B.

The secondary objective of this study is to evaluate the efficacy of rFIXFc in the prevention and treatment of bleeding episodes.

Full description

Participants will follow either a prophylaxis or on-demand regimen. The starting dose in this study will be determined by the clinical profile of the patient in the preceding studies, B-LONG 998HB102 (NCT01027364) and Kids B-LONG study 9HB02PED (NCT01440946)

Enrollment: 120 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Subjects who have completed studies 998HB102 (NCT01027364) or 9HB02PED (NCT01440946) or other studies with rFIXFc
• Ability to understand the purposes & risks of the study and provide signed and dated informed consent.

Key Exclusion Criteria:

• High-titer inhibitor (>/=5.00 BU/mL)

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

On-Demand

Experimental group

Description:

The individual dose of rFIXFc to treat bleeding episodes will be based on participant's clinical condition, type and severity of the bleeding event, and if indicated, Factor IX peak (recovery) levels.

Treatment:

Biological: rFIXFc

Prophylaxis

Experimental group

Description:

Weekly prophylaxis, individualized prophylaxis or personalized prophylaxis available.

Treatment:

Biological: rFIXFc