Clinical trial
Pharmacokinetics, Efficacy and Safety Study of IMMUNATE SD (Human Plasma-Derived…
NCT00162019 · Baxalta now part of Shire, Industry · Completed
Key facts
| NCT number | NCT00162019 |
|---|---|
| Title | Pharmacokinetics, Efficacy and Safety Study of IMMUNATE SD (Human Plasma-Derived Coagulation Factor VIII Concentrate) in Hemophilia A Patients |
| Official title | Phase 3, Prospective, Multicenter Study to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Efficacy of IMMUNATE Solvent Detergent (IMMUNATE SD) in Previously Treated Patients With Severe or Moderately Severe Hemophilia A |
| Lead sponsor | Baxalta now part of Shire, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Hemophilia A |
| Intervention type | Drug |
| Interventions | Human Plasma-Derived Coagulation Factor VIII Concentrate (Virus Inactivated by Polysorbate 80 Treatment and Vapor Heat Treatment) |
| Enrollment | 56 |
| Start date | Mar 31, 2003 |
| Primary completion | Aug 24, 2004 |
| Completion | Aug 24, 2004 |
| First posted | Sep 13, 2005 |
| Last update posted | Apr 29, 2021 |
| Countries | Bulgaria, Czechia, Hungary, Poland |
At a glance
- 1–9 Study sites
- No 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: