Completed PHASE3 INTERVENTIONAL 4-arm NCT01027364

Study of Recombinant Factor IX Fc Fusion Protein (rFIXFc) in Participants With Hemophilia B

B-LONG: An Open-Label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant, Long-acting Coagulation Factor IX Fc Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia B

Sponsor: Bioverativ Therapeutics Inc.

Conditions Severe Hemophilia B

Interventions Factor IX (rFIXFc) rFIX

Updated 9 times since 2017 Last updated: Dec 16, 2020 Started: Dec 31, 2009 Primary completion: Jul 31, 2012 Completion: Jul 31, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01027364, this PHASE3 trial focuses on Severe Hemophilia B and remains completed. Sponsored by Bioverativ Therapeutics Inc., it has been updated 9 times since 2009, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

9 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Oct 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 4 earlier versions

Jun 2018 — Oct 2018 [monthly]

Completed PHASE3
May 2017 — Jun 2018 [monthly]

Completed PHASE3
Feb 2017 — May 2017 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Dec 2009

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Bioverativ Therapeutics Inc.
Swedish Orphan Biovitrum

Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Adelaide, Australia , Aurora, United States , Bangalore, India , Beijing, China , Berlin, Germany , Bonn, Germany , Brussels, Belgium , Calgary, Canada , Cambridge, United Kingdom , Camperdown, Australia and 41 more locations