Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00168051
First received: September 11, 2005
Last updated: February 7, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemophilia A |
Drug: ReFacto Drug: Advante |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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) |
Resource links provided by NLM:
Genetics Home Reference related topics:
hemophilia
MedlinePlus related topics:
Hemophilia
U.S. FDA Resources
Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Primary Outcome Measures:
- Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.
Secondary Outcome Measures:
- 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.
| Enrollment: | 21 |
| Study Start Date: | April 2005 |
| Study Completion Date: | November 2005 |
| Primary Completion Date: | November 2005 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 64 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168051
Locations
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Iowa | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States, 70112 | |
| 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 | |
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
| 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 |
More Information
No publications provided
| Responsible Party: | Wyeth is now a wholly owned subsidiary of Pfizer |
| ClinicalTrials.gov Identifier: | NCT00168051 History of Changes |
| Other Study ID Numbers: | 3082A-101711/3082A1-900 |
| Study First Received: | September 11, 2005 |
| Last Updated: | February 7, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
|
Hemophilia A |
Additional relevant MeSH terms:
|
Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases Coagulation Protein Disorders Hemorrhagic Disorders |
Genetic Diseases, Inborn Factor VIII Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013