Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A
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)
1 other identifier
interventional
N/A
8 countries
13
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2005
Shorter than P25 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 11, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2005
CompletedSeptember 25, 2018
February 1, 2013
7 months
September 11, 2005
September 24, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.
Secondary Outcomes (1)
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.
Interventions
Eligibility Criteria
You may qualify if:
- Severe hemophilia A
- Previously treated patients with at least 150 exposure days to any Factor VIII product
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Unknown Facility
Washington D.C., District of Columbia, 20007, United States
Unknown Facility
Atlanta, Georgia, 30322, United States
Unknown Facility
Iowa City, Iowa, 52242, United States
Unknown Facility
New Orleans, Louisiana, 70112, United States
Unknown Facility
Brussels, 1200, Belgium
Unknown Facility
Paris, 75747, France
Unknown Facility
Berlin, 10249, Germany
Unknown Facility
Münster, 48143, Germany
Unknown Facility
Milan, 20122, Italy
Unknown Facility
Amsterdam, Netherlands
Unknown Facility
Utrecht, 3584 CX, Netherlands
Unknown Facility
Christchurch, 8001, New Zealand
Unknown Facility
Manchester, M13 9WL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Wyeth is now a wholly owned subsidiary of Pfizer
- PRINCIPAL INVESTIGATOR
Trial Manager
For Germany, MedInfoDEU@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Italy, descresg@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Belgium, trials-BEL@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For Netherlands, trials-NL@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For New Zealand, medinfo@wyeth.com
- PRINCIPAL INVESTIGATOR
Trial Manager
For UK, ukmedinfo@wyeth.com
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 11, 2005
First Posted
September 14, 2005
Study Start
April 1, 2005
Primary Completion
November 1, 2005
Study Completion
November 1, 2005
Last Updated
September 25, 2018
Record last verified: 2013-02