Clinical trial
Efficacy and Safety Study of a Recombinant Protein-Free Manufactured Factor VIII…
NCT00157157 · Baxalta now part of Shire, Industry · Completed
Key facts
| NCT number | NCT00157157 |
|---|---|
| Title | Efficacy and Safety Study of a Recombinant Protein-Free Manufactured Factor VIII (rAHF-PFM) in Previously Untreated Hemophilia A Patients |
| Official title | Recombinant Antihemophilic Factor Manufactured and Formulated Without Added Human or Animal Proteins (rAHF-PFM): Evaluation of Immunogenicity, Efficacy, and Safety in Previously Untreated Patients With Hemophilia A |
| Lead sponsor | Baxalta now part of Shire, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Hemophilia A |
| Intervention type | Biological |
| Interventions | Recombinant Antihemophilic Factor Manufactured and Formulated without Added Human or Animal Proteins (rAHF-PFM) |
| Enrollment | 66 |
| Start date | Apr 1, 2004 |
| Primary completion | Sep 11, 2009 |
| Completion | Sep 11, 2009 |
| First posted | Sep 12, 2005 |
| Last update posted | May 24, 2021 |
| Countries | Austria, Canada, France, Germany, Italy, Puerto Rico, Spain, Sweden, United Kingdom, United States |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: