NCT01425723 (B-YOND) is a Phase 3 clinical trial of rFIXFc in Severe Hemophilia B, sponsored by Bioverativ Therapeutics Inc..

Who is sponsoring NCT01425723?

NCT01425723 is sponsored by Bioverativ Therapeutics Inc..

What drugs are being tested in NCT01425723?

Interventions in NCT01425723: rFIXFc.

What condition does NCT01425723 study?

NCT01425723 studies Severe Hemophilia B.

Is NCT01425723 still recruiting?

NCT01425723 is currently completed. Last updated 16 December 2020.

Are results published for NCT01425723?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-12-16 · How we verify

NCT01425723: B-YOND

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

An Open-Label, Multicenter, Evaluation of the Long-Term Safety and Efficacy of Recombinant Human Coagulation Factor IX Fusion Protein (rFIXFc) in the Prevention and Treatment of Bleeding Episodes in Previously Treated Subjects With Hemophilia B

Completed Phase 3 Results posted Last updated 16 December 2020

What this trial tests

Phase 3 trial testing rFIXFc in Severe Hemophilia B in 120 participants. Completed in 1 October 2017.

Timeline

8 December 2011

Primary endpoint
1 October 2017

1 October 2017

Quick facts

Lead sponsor	Bioverativ Therapeutics Inc.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	120
Start date	8 December 2011
Primary completion	1 October 2017
Estimated completion	1 October 2017
Sites	49 locations across United States, Australia, Belgium, Brazil, Canada, China, France, Germany

Drugs / interventions tested

rFIXFc — full drug profile →

Conditions studied

Severe Hemophilia B — all drugs for Severe Hemophilia B →

Sponsor

Bioverativ Therapeutics Inc. — full company profile →

Who can join

Eligibility, male only, with Severe Hemophilia B. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of Participants With Any Positive Inhibitor Development
Time frame: Approximately 5 years
An inhibitor test result greater than or equal to (\>=)0.6 Bethesda units per milliliter (BU/mL), confirmed on 2 separate samples drawn 2 to 4 weeks apart, was considered positive. Both tests were to be performed by the central laboratory using the Nijmegen-modified Bethesda Assay. Data was summarized by treatment regimen for participants from Study 998HB102 and by age cohort (\<6 years and 6 to \

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Outcome of Clinical Trials with New Extended Half-Life FVIII/IX Concentrates.
Mancuso ME, Santagostino E. · · 2017 · cited 72× · PMID 28350322 · DOI 10.3390/jcm6040039
Long-term safety and sustained efficacy for up to 5 years of treatment with recombinant factor IX Fc fusion protein in subjects with haemophilia B: Results from the B-YOND extension study.
Pasi KJ, Fischer K, Ragni M, Kulkarni R, et al · · 2020 · cited 37× · PMID 32497409 · DOI 10.1111/hae.14036
New therapies for hemophilia.
Pipe SW. · · 2016 · cited 25× · PMID 27913542 · DOI 10.1182/asheducation-2016.1.650
Real-world data demonstrate improved bleed control and extended dosing intervals for patients with haemophilia B after switching to recombinant factor IX Fc fusion protein (rFIXFc) for up to 5 years.
Shapiro A, Chaudhury A, Wang M, Escobar M, et al · · 2020 · cited 17× · PMID 33012060 · DOI 10.1111/hae.14152
Fc-fusion technology and recombinant FVIII and FIX in the management of the hemophilias.
Mancuso ME, Mannucci PM. · · 2014 · cited 17× · PMID 24729686 · DOI 10.2147/dddt.s47312
Managing surgery in hemophilia with recombinant factor VIII Fc and factor IX Fc: Data on safety and effectiveness from phase 3 pivotal studies.
Chowdary P, Holmström M, Mahlangu JN, Ozelo MC, et al · · 2022 · cited 11× · PMID 35910942 · DOI 10.1002/rth2.12760
Extending recombinant factor IX Fc fusion protein dosing interval to 14 or more days in patients with hemophilia B.
Shapiro AD, Pasi KJ, Ozelo MC, Kulkarni R, et al · · 2019 · cited 9× · PMID 30656283 · DOI 10.1002/rth2.12163
Real-World Effectiveness of rFIXFc Prophylaxis in Patients with Haemophilia B Switched from Standard Half-Life Therapy in Three European Countries.
Funding E, Lowe G, Poulsen LH, Shapiro S, et al · · 2023 · cited 6× · PMID 37351812 · DOI 10.1007/s12325-023-02559-1

Verify or expand the search:

Other trials of rFIXFc

Trials testing the same drug.

NCT02234310 — Study to Determine the Safety and Efficacy of rFIXFc in Previously Untreated Males With Severe Hemophilia B · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01425723 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Bioverativ Therapeutics Inc.
Last refreshed: 16 December 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01425723.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing