NCT00749476 is a Phase 4 clinical trial of Factor IX recovery in Hemophilia B, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

Who is sponsoring NCT00749476?

NCT00749476 is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

What drugs are being tested in NCT00749476?

Interventions in NCT00749476: Factor IX recovery.

What condition does NCT00749476 study?

NCT00749476 studies Hemophilia B.

Is NCT00749476 still recruiting?

NCT00749476 is currently completed. Last updated 6 June 2011.

Are results published for NCT00749476?

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

Last reviewed 2011-06-06 · How we verify

NCT00749476

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

Reformulated BeneFIX Efficacy and Safety After Conversion From a pdFIX

Completed Phase 4 Results posted Last updated 6 June 2011

What this trial tests

Phase 4 trial testing Factor IX recovery in Hemophilia B in 1 participant. Completed in 1 January 2009.

Timeline

1 April 2008

Primary endpoint
1 January 2009

1 January 2009

Quick facts

Lead sponsor	Wyeth is now a wholly owned subsidiary of Pfizer
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Enrollment	1
Start date	1 April 2008
Primary completion	1 January 2009
Estimated completion	1 January 2009
Sites	8 locations across France

Drugs / interventions tested

Factor IX recovery — full drug profile →

Conditions studied

Hemophilia B — all drugs for Hemophilia B →

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer — full company profile →

Who can join

12 and older, male only, with 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 Reporting Efficacy
Time frame: 4 months
Clinical efficacy was measured by number/location of bleeding episodes, number of injections per bleeding, factor IX consumption, global assessment of efficacy by investigator and patient; biological efficacy (recovery) with BeneFIX was measured just after conversion.

Sponsor's own description

The purpose of this study is to collect data around the period of the conversion from plasma-derived Factor IX (pdFIX) to BeneFIX. The main information collected will be: a retrospective history of the bleedings in the 3-month period before the conversion, the recovery with pdFIX just before the conversion and with BeneFIX just after the conversion, and a prospective history of the bleedings in the 3 month period following the conversion.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Hemophilia B

Currently open trials in the same condition.

NCT07080905 — Phase 3, Open-label, Single-dose Study of CSL222 in Adolescent Male Subjects (≥ 12 to < 18 Years of Age) With Severe or · Phase 3 · recruiting
NCT06727669 — Longitudinal Cohort of Thrombosis and Hemostasis Diseases · recruiting
NCT06565481 — Measurement Properties in People with Hemophilia · NA · recruiting
NCT06379789 — A Study to Investigate the Safety and Effectiveness of a Coagulation Factor IX Gene Insertion Therapy (REGV131-LNP1265) · Phase 1, PHASE2 · recruiting
NCT06399289 — Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Chinese Subjects With Hemophilia B Pre · Phase 3 · active not recruiting

Other Wyeth is now a wholly owned subsidiary of Pfizer trials

Trials by the same sponsor.

NCT00909688 — Study to Evaluate Whether BLI-489 Can be Safely Tolerated by Healthy Subjects Given Multiple Doses · Phase 1 · completed
NCT00853749 — Immune Response In Children Revaccinated With Pneumococcal Conjugate Vaccine · Phase 3 · completed
NCT00894634 — Study Evaluating Brompheniramine Maleate Liquid in Children and Adolescents · Phase 1 · completed
NCT00854009 — Study Evaluating Single Doses of BLI-489 in Healthy Japanese Male Subjects · Phase 1 · completed
NCT00837837 — Study Evaluating Chlorpheniramine Maleate Liquid in Children and Adolescents · Phase 1 · 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 NCT00749476 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Wyeth is now a wholly owned subsidiary of Pfizer
Last refreshed: 6 June 2011

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/NCT00749476.

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