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Sponsored by: |
Wyeth |
---|---|
Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00037544 |
To characterize the safety and efficacy of ReFacto AF in treating acute bleeding episodes during prophylaxis treatment, including neoantigenicity.
Condition | Intervention | Phase |
---|---|---|
Hemophilia A |
Drug: ReFacto AF |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | An Open-Label Study to Characterize the Safety and Efficacy of BDDrFVIII Manufactured by the Albumin Free Process (ReFacto AF) in the Treatment of Previously Treated Patients (PTP) With Severe Hemophilia A |
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 3082B1-306 |
Study First Received: | May 17, 2002 |
Last Updated: | April 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00037544 |
Health Authority: | United States: Food and Drug Administration |
Severe Hemophilia A |
Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases Blood Coagulation Disorders |
Hemophilia A Hemostatic Disorders Factor VIII |
Blood Coagulation Disorders, Inherited Coagulation Protein Disorders |