BeneFIX

DRUG8 trials

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer, Pfizer, Baxalta now part of Shire, Grifols Biologicals, LLC, ISU Abxis Co., Ltd.

Conditions

HEMOPHILIA BHemophilia B

Phase 1

An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B

CompletedNCT02213250

PfizerHemophilia B

Start: 2015-03-31End: 2015-04-30Updated: 2016-07-25

Dose-escalation Study to Investigate the Safety, PK, and PD of ISU304/CB2679d in Hemophilia B Patients

CompletedNCT03186677

ISU Abxis Co., Ltd.Hemophilia B

Start: 2017-06-03End: 2019-02-22Updated: 2020-11-10

Phase 2

Efficacy and Safety of AlphaNine Versus BeneFIX in Patients With Severe Hereditary Haemophilia B

CompletedNCT03091751

Grifols Biologicals, LLCHemophilia B

Start: 2005-08-31End: 2009-10-31Updated: 2017-07-25

Phase 3

Study Evaluating rFIX; BeneFIX in Severe Hemophilia B

CompletedNCT00037557

Wyeth is now a wholly owned subsidiary of PfizerHemophilia B

Start: 2002-09-30End: 2007-11-30Target: 20Updated: 2007-12-27

Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects

CompletedNCT00866606

Wyeth is now a wholly owned subsidiary of PfizerHemophilia B

Start: 2009-02-28End: 2009-12-31Updated: 2011-04-05

Pivotal Study (Pharmacokinetics, Efficacy, Safety) of BAX 326 (rFIX) in Hemophilia B Patients

CompletedNCT01174446

Baxalta now part of ShireHemophilia B

Start: 2010-07-29End: 2012-05-03Updated: 2021-05-20

Phase 4

Safety and Efficacy of Benefix in Patients With Hemophilia B in Usual Care Settings in China

CompletedNCT02336178

PfizerHEMOPHILIA B

Start: 2015-01-31End: 2016-08-31Updated: 2017-05-04

Unknown Phase

Registry For Patients Treated With BeneFix In Usual Care Setting In Germany

CompletedNCT00714415

PfizerHemophilia B

Start: 2008-01-31End: 2016-10-31Updated: 2018-10-25

Related Papers

Population Modeling of Factor IX Activity Following Administration of Fidanacogene Elaparvovec Gene Therapy in Participants with Hemophilia B

Clinical Pharmacokinetics2025-08-014 citations

Model-Informed Support of Dose Selection for Prophylactic Treatment with Dalcinonacog Alfa in Adult and Paediatric Hemophilia B Patients.

2023-06-211 citations

First open-label, single-arm, prospective study of real-world use of FIX replacement therapy in a predominantly pediatric hemophilia B population in China

Medicine2021-05-254 citations

Safety, pharmacokinetics, and pharmacodynamics of a next-generation subcutaneously administered coagulation factor IX variant, dalcinonacog alfa, in previously treated hemophilia B patients.

2021-03-249 citations

Safety, Immunogenicity, and Hemostatic Efficacy of Nonacog Gamma in Patients With Severe or Moderately Severe Hemophilia B: A Continuation Study

Clinical and Applied Thrombosis/Hemostasis2020-01-013 citations

Phase 3 Clinical Trial: Perioperative Use of Nonacog Gamma, a Recombinant Factor IX, in Previously Treated Patients With Moderate/Severe Hemophilia B

Clinical and Applied Thrombosis/Hemostasis2020-01-011 citations

Evaluation of the Safety, Immunogenicity, and Hemostatic Efficacy of Nonacog Gamma (BAX326) in Previously Treated and Naïve Patients with Severe or Moderately Severe Hemophilia B: A Continuation Study

Blood2018-11-29