Study to Establish Bioequivalence of ReFacto AF (BDDrFVIII) With Advate (FLrFVIII) in Hemophilia A

Hemophilia A Clinical Trial

Official title:

A Randomized Two-Way Blinded Crossover-Design Study to Establish the Bioequivalence of B-Domain Deleted Recombinant Factor VIII (BDDrFVIII,Refacto AF) With a Full Length Recombinant Factor VIII Preparation (FLrFVIII,Advate), Followed by an Open-Label Trial of the Safety and Efficacy of ReFacto AF in Previously Treated Patients With Hemophilia A.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00141843
• Other study ID #: 3082B2-310
• Status: Completed
• Phase: Phase 3
• First received: August 30, 2005
• Last updated: April 21, 2008
• Start date: July 2005
• Est. completion date: November 2006

Study information

• Verified date: April 2008
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Institutional Review BoardFrance: Ministry of HealthGermany: Ethics CommissionItaly: Ministry of HealthMali: Ministry of HealthBulgaria: Bulgarian Drug AgencyGreece: National Organization of MedicinesTurkey: Ministry of HealthSpain: Ministry of HealthPortugal: National Pharmacy and Medicines InstituteUnited Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of HealthSwitzerland: SwissmedicIsrael: Israeli Health Ministry Pharmaceutical AdministrationHungary: National Institute of PharmacyCroatia: Ministry of Health and Social CarePoland: Ministry of HealthCzech Republic: State Institute for Drug ControlUnited Kingdom: National Health ServiceAustralia: Human Research Ethics CommitteeNew Zealand: Health Research CouncilTaiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

The study will consist of two parts: a safety and efficacy period in which all subjects will participate and a pharmacokinetic analysis period, in which 30 eligible subjects will participate to compare ReFacto AF and Advate bioequivalency and safety and efficacy of ReFacto AF in patients with Hemophilia A.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• Male subjects with severe or moderately severe hemophilia A

• A negative past medical history of a Factor VIII inhibitor

• Age greater than or equal to 12 years

Exclusion Criteria:

• A history of Factor VIII inhibitors

• Presence of a bleeding disorder in addition to hemophilia

• Known hypersensitivity to hamster protein

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Genetic:
• ReFacto AF

• B-Domain deleted Recombinant Factor VIII

• BDDrFVIII

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Finland,  France,  Germany,  Hungary,  Italy,  Netherlands,  New Zealand,  Poland,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the incidence rate of Factor VIII inhibitors in the study patient population.To establish bioequivalence of ReFacto AF as compared to Advate using the one stage Factor VIII activity assay.
Secondary	To characterize the efficacy of ReFActo AF in preventing and treating bleeding episodes during prophylaxis.To characterize PK of ReFacto AF as compared to Advate over time.