Clinical trial
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic…
NCT02622321 · Hoffmann-La Roche, Industry · Completed
Key facts
| NCT number | NCT02622321 |
|---|---|
| Title | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Participants With Inhibitors |
| Official title | A Randomized, Multicenter, Open-Label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus no Prophylaxis in Hemophilia A Patients With Inhibitors |
| Acronym | HAVEN 1 |
| Lead sponsor | Hoffmann-La Roche, Industry |
| Collaborators | Chugai Pharmaceutical Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Hemophilia A |
| Intervention type | Drug |
| Interventions | Emicizumab, rFVIIa, aPCC |
| Enrollment | 113 |
| Start date | Nov 18, 2015 |
| Primary completion | Oct 25, 2016 |
| Completion | Dec 1, 2020 |
| First posted | Dec 4, 2015 |
| Last update posted | Jun 24, 2021 |
| Countries | Australia, Costa Rica, France, Germany, Italy, Japan, New Zealand, Poland, South Africa, South Korea, Spain, Taiwan and 2 more |
At a glance
- 10–99 Study sites
- 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: