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.
- Severe hemophilia A
- Previously treated patients with at least 150 exposure days to any Factor VIII product
- 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
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A | |||||||||||||||||||||
| Official Title ICMJE | 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) | |||||||||||||||||||||
| 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. | |||||||||||||||||||||
| Detailed Description | Not Provided | |||||||||||||||||||||
| Study Type ICMJE | Interventional | |||||||||||||||||||||
| Study Phase ICMJE | Phase 4 | |||||||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Primary Purpose: Treatment | |||||||||||||||||||||
| Condition ICMJE | Hemophilia A | |||||||||||||||||||||
| Intervention ICMJE |
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| Study Arms ICMJE | Not Provided | |||||||||||||||||||||
| Publications * | Not Provided | |||||||||||||||||||||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||||||||||||||||||||
| Recruitment Information | ||||||||||||||||||||||
| Recruitment Status ICMJE | Withdrawn | |||||||||||||||||||||
| Actual Enrollment ICMJE | 0 | |||||||||||||||||||||
| Original Enrollment ICMJE | 30 | |||||||||||||||||||||
| Actual Study Completion Date ICMJE | November 2005 | |||||||||||||||||||||
| Actual Primary Completion Date | November 2005 (Final data collection date for primary outcome measure) | |||||||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 64 Years (Adult) | |||||||||||||||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||||||||||||||
| Listed Location Countries ICMJE | Belgium, France, Germany, Italy, Netherlands, New Zealand, United Kingdom, United States | |||||||||||||||||||||
| Removed Location Countries | ||||||||||||||||||||||
| Administrative Information | ||||||||||||||||||||||
| NCT Number ICMJE | NCT00168051 | |||||||||||||||||||||
| Other Study ID Numbers ICMJE | 3082A-101711 | |||||||||||||||||||||
| Has Data Monitoring Committee | Not Provided | |||||||||||||||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||||||||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||||||||||||||
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||||||||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||||||||
| Collaborators ICMJE | Not Provided | |||||||||||||||||||||
| Investigators ICMJE |
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| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||||||||||||||||||||
| Verification Date | February 2013 | |||||||||||||||||||||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||||||||||||||||||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
