Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A

September 24, 2018 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1200
  • France
      • Paris, France, 75747
  • Germany
      • Berlin, Germany, 10249
      • Munster, Germany, 48143
  • Italy
      • Milano, Italy, 20122
  • Netherlands
      • Amsterdam, Netherlands
      • Utrecht, Netherlands, 3584 CX
  • New Zealand
      • Christchurch, New Zealand, 8001
  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
    • Georgia
      • Atlanta, Georgia, United States, 30322
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Louisiana
      • New Orleans, Louisiana, United States, 70112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

November 1, 2005

Study Completion (ACTUAL)

November 1, 2005

Study Registration Dates

First Submitted

September 11, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (ESTIMATE)

September 14, 2005

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2018

Last Update Submitted That Met QC Criteria

September 24, 2018

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3082A-101711

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hemophilia A

Clinical Trials on ReFacto

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hong Kong

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe