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

Primary Purpose

Hemophilia A

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

ReFacto AF

B-Domain deleted Recombinant Factor VIII

BDDrFVIII

About this trial

This is an interventional prevention trial for Hemophilia A focused on measuring Hemophilia A

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

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 Outcome Measures

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.

Full Information

NCT ID

NCT00141843

First Posted

August 30, 2005

Last Updated

April 21, 2008

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00141843

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

July 2005 (undefined)

Primary Completion Date

November 2006 (Actual)

Study Completion Date

November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hemophilia A

Keywords

Hemophilia A

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Genetic

Intervention Name(s)

ReFacto AF

Intervention Type

Genetic

Intervention Name(s)

B-Domain deleted Recombinant Factor VIII

Intervention Type

Genetic

Intervention Name(s)

BDDrFVIII

Primary Outcome Measure Information:

Title

Secondary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: