Back to results

Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

Primary Purpose

Hemophilia A

Status

Withdrawn

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

ReFacto

Advante

About this trial

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

Eligibility Criteria

18 Years - 64 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Severe hemophilia A Previously treated patients with at least 150 exposure days to any Factor VIII product Exclusion Criteria: Hypersensitivity to any recombinant Factor VIII product History of or current Factor VIII inhibitor Bleeding episode or other reason requiring Factor VIII treatment within 3 days of study

Sites / Locations

Outcomes

Primary Outcome Measures

Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.

Secondary Outcome Measures

Number of subjects who experience any adverse event or develop Factor VIII inhibitor at study termination, 48 hours post dosing and/or at the final study visit within seven days of the 2nd period of the study.

Full Information

NCT ID

NCT00168051

First Posted

September 11, 2005

Last Updated

September 24, 2018

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT00168051

Brief Title

Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

Official Title

A Single Dose, Randomized, 2-Period Crossover Study in Patients With Hemophilia A to Evaluate the Pharmacokinetics of ReFacto (B-domain Deleted Recombinant Human Factor VIII (BDDrFVIII) and Advante (a Full-length Recombinant Factor VIII (FLrFVIII)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Withdrawn

Study Start Date

April 2005 (undefined)

Primary Completion Date

November 2005 (Actual)

Study Completion Date

November 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

5. Study Description

Brief Summary

The purpose of the study is to compare the pharmacokinetic parameters of ReFacto and Advate, using the chromogenetic substrate assay to measure plasma Factor VIII activity in plasma.

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

Treatment

Study Phase

Phase 4

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

ReFacto

Intervention Type

Drug

Intervention Name(s)

Advante

Primary Outcome Measure Information:

Title

Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.

Secondary Outcome Measure Information:

Title

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: