Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Baxter Healthcare Corporation Baxter BioScience |
---|---|
Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00214734 |
The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice.
Condition | Intervention |
---|---|
Hemophilia A |
Drug: rAHF-PFM |
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Defined Population, Prospective Study |
Official Title: | Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A– An ADVATE Post-Authorization Safety Surveillance (PASS) Study |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Study Director: | Bruce Ewenstein, MD | Baxter BioScience |
Study ID Numbers: | ADVATE PASS |
Study First Received: | September 15, 2005 |
Last Updated: | May 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00214734 |
Health Authority: | United States: Food and Drug Administration |
Hemorrhagic Disorders Genetic Diseases, Inborn Hematologic Diseases Blood Coagulation Disorders |
Hemophilia A Hemostatic Disorders Factor VIII |
Blood Coagulation Disorders, Inherited Coagulation Protein Disorders |