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NCT03347396 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Bioverativ, a Sanofi company.
- Completed
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
NCT03347396 is a Phase 3 study that has completed, run by Bioverativ, a Sanofi company. The registered enrollment target is 24 participants.
The verdict
NCT03347396, a Phase 3 study, has completed, sponsored by Bioverativ, a Sanofi company.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (\>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increased Hgb to \>= 12 g/dL and obviated the need for blood transfusion during treatment in participants with primary cold agglutinin disease (CAD) who had a recent history of blood transfusion. The purpose of Part B was to evaluate the long-term safety and tolerability of sutimlimab in participants with CAD.
Interventions
- DRUG BIVV009
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-03-05 |
| Est. Completion | 2021-10-05 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03347396
The ClinicalTrials.gov registry entry for NCT03347396 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bioverativ, a Sanofi company, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which BIVV009 is the first listed.
NCT03347396 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03347396 about?
NCT03347396 is a clinical study titled "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)". The purpose of Part A was to determine whether sutimlimab administration resulted in a greater than or equal to (\>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb) levels or increased Hgb to \>= 12 g/dL and obviated the need for blood transfusion during treatment in participants with pri...
What is the current status of trial NCT03347396?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2018-03-05. Estimated completion is 2021-10-05.
What interventions are being tested in trial NCT03347396?
The interventions under investigation include: BIVV009 (DRUG).
Who is sponsoring clinical trial NCT03347396?
This trial is sponsored by Bioverativ, a Sanofi company, which has 14 total clinical trials registered on ClinicalTrials.gov.
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