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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00168051 |
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Date of registration:
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11/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study Comparing Blood Levels of ReFacto and Advante in Hemophilia A
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Scientific title:
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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) |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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0 |
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Recruitment status: |
Withdrawn |
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URL:
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https://clinicaltrials.gov/show/NCT00168051 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double.
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Phase:
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Phase 4
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Countries of recruitment
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Belgium
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France
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Germany
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Italy
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Netherlands
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New Zealand
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United Kingdom
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United States
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Contacts
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For UK, ukmedinfo@wyeth.com |
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Name:
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Medical Monitor |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wyeth is now a wholly owned subsidiary of Pfizer |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Italy, descresg@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Belgium, trials-BEL@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Germany, MedInfoDEU@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For Netherlands, trials-NL@wyeth.com |
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Name:
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Trial Manager |
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Address:
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Telephone:
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Email:
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Affiliation:
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For New Zealand, medinfo@wyeth.com |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Hemophilia A
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Intervention(s)
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Drug: Advante
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Drug: ReFacto
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Primary Outcome(s)
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Pharmacokinetic measurement of area under the plasma Factor VIII activity in plasma versus time curve for 48 hours.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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3082A-101711
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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