Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A
NCT00168051
Last updated date
ABOUT THIS STUDY
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.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia A
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-64 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Severe hemophilia A
- Previously treated patients with at least 150 exposure days to any Factor VIII product
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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
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Advanced Information
| 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 |
| |||||||||||||||||||||
| 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:
| |||||||||||||||||||||
| Sex/Gender ICMJE |
| |||||||||||||||||||||
| 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 |
| |||||||||||||||||||||
| 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 | ||||||||||||||||||||||