Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hemophilia A
Intervention: ReFacto (Drug); Advante (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Germany, MedInfoDEU@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Italy, descresg@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Belgium, trials-BEL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For Netherlands, trials-NL@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For New Zealand, medinfo@wyeth.com
Trial Manager, Principal Investigator, Affiliation: For UK, ukmedinfo@wyeth.com
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.
Clinical Details
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 design: Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.
Secondary outcome: 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 64 Years.
Gender(s): Male.
Criteria:
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
Locations and Contacts
Brussels 1200, Belgium
Paris 75747, France
Munster 48143, Germany
Berlin 10249, Germany
Milano 20122, Italy
Amsterdam, Netherlands
Utrecht 3584 CX, Netherlands
Christchurch 8001, New Zealand
Manchester M13 9WL, United Kingdom
Washington, District of Columbia 20007, United States
Atlanta, Georgia 30322, United States
Iowa City, Iowa 52242, United States
New Orleans, Louisiana 70112, United States
Additional Information
Starting date: April 2005
Last updated: October 9, 2007
|
