Clinical trial
A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in…
NCT03347396 · Bioverativ, a Sanofi company, Industry · Completed
Key facts
| NCT number | NCT03347396 |
|---|---|
| Title | A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study) |
| Official title | A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion |
| Lead sponsor | Bioverativ, a Sanofi company, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Agglutinin Disease, Cold |
| Intervention type | Drug |
| Interventions | BIVV009 |
| Enrollment | 24 |
| Start date | Mar 5, 2018 |
| Primary completion | Oct 5, 2021 |
| Completion | Oct 5, 2021 |
| First posted | Nov 20, 2017 |
| Last update posted | Oct 31, 2022 |
| Countries | Australia, Austria, Belgium, Canada, France, Germany, Israel, Italy, Japan, Netherlands, Norway, Spain 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: