NCT00866606 is a Phase 3 clinical trial of Benefix in Hemophilia B, sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

Who is sponsoring NCT00866606?

NCT00866606 is sponsored by Wyeth is now a wholly owned subsidiary of Pfizer.

What drugs are being tested in NCT00866606?

Interventions in NCT00866606: Benefix.

What condition does NCT00866606 study?

NCT00866606 studies Hemophilia B.

Is NCT00866606 still recruiting?

NCT00866606 is currently completed. Last updated 1 April 2011.

Are results published for NCT00866606?

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

Last reviewed 2011-04-01 · How we verify

NCT00866606

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

An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With BeneFIX (Nonacog Alfa, Recombinant Factor IX) In Chinese Subjects With Hemophilia B

Completed Phase 3 Results posted Last updated 1 April 2011

What this trial tests

Phase 3 trial testing Benefix in Hemophilia B in 35 participants. Completed in 1 December 2009.

Timeline

1 February 2009

Primary endpoint
1 December 2009

1 December 2009

Quick facts

Lead sponsor	Wyeth is now a wholly owned subsidiary of Pfizer
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	1 February 2009
Primary completion	1 December 2009
Estimated completion	1 December 2009
Sites	6 locations across China

Drugs / interventions tested

Benefix — 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

6 and older, any sex, 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.

Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion
Time frame: 8 hours post infusion
Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): proba
Investigator Hemostatic Efficacy Assessment of Participants After 24 Hours Post Infusion
Time frame: 24 hours post infusion
Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): proba
Percentage of Participants With FIX Inhibitor Development
Time frame: Baseline up to 6 months
Incidence of FIX inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory with Nijmegen assay result \>=0.6 Bethesda Unit (BU). Incidence was stratified by participant exposure history - Minimally Treated Patients (MTPs): those who had received at least one prior FIX infusion, and \<= 100 documented Exposure Days (EDs); while Previously Tr

Sponsor's own description

This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.

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 NCT00866606 (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: 1 April 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/NCT00866606.

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