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NCT04669600 · ClinicalTrials.gov registry record · Phase 2
A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)
A Phase 2 study, sponsored by Bioverativ, a Sanofi company.
- Completed
- Registry status
- Phase 2
- Development phase
- 12
- Enrollment target
NCT04669600: Completed Phase 2 study, sponsored by Bioverativ, a Sanofi company.
NCT04669600 is a Phase 2 study that has completed, run by Bioverativ, a Sanofi company. The registered enrollment target is 12 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04669600, a Phase 2 study, has completed, sponsored by Bioverativ, a Sanofi company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 12 participants
- Enrollment target
Study Summary
Primary Objective: \- To evaluate the effect of BIVV020 on the durability of platelet response in participants with persistent/chronic immune thrombocytopenia (ITP) Secondary Objectives: * To assess the safety and tolerability of BIVV020 * To assess the pharmacokinetics of BIVV020 * To assess the response rate of treatment with BIVV020 * To assess the time to response * To assess the effect of treatment with BIVV020 on the requirement for rescue ITP therapy * To assess the immunogenicity of BIVV020
Primary Outcome
A naive participant was a participant who did not use sutimlimab prior to enrollment. A switcher was a participant who used sutimlimab prior to enrollment. A naive participant was a responder if the platelet count was \>=50 × 10\^9/liter (L) at \>=50 percent (%) of scheduled visits, or for participants with baseline platelet count \<15 × 10\^9/L, a \>=20 × 10\^9/L increase in platelet count from baseline at \>=50% of scheduled visits, without receiving rescue immune thrombocytopenia (ITP) therap
Interventions
- DRUG SAR445088 (BIVV020)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-02-04 |
| Est. Completion | 2023-02-07 |
| Phase | Phase 2 |
What the finished NCT04669600 record still lists
NCT04669600 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which SAR445088 (BIVV020) is the first listed.
NCT04669600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04669600 about?
NCT04669600 is a clinical study titled "A Phase 2a Study Evaluating BIVV020 in Adults With Persistent/Chronic Immune Thrombocytopenia (ITP)". Primary Objective: \- To evaluate the effect of BIVV020 on the durability of platelet response in participants with persistent/chronic immune thrombocytopenia (ITP) Secondary Objectives: * To assess the safety and tolerability of BIVV020 * To assess the pharmacokinetics of BIVV020 * To assess the...
What is the current status of trial NCT04669600?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 12 participants. The study started on 2021-02-04. Estimated completion is 2023-02-07.
What interventions are being tested in trial NCT04669600?
The interventions under investigation include: SAR445088 (BIVV020) (DRUG).
Who is sponsoring clinical trial NCT04669600?
This trial is sponsored by Bioverativ, a Sanofi company, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04669600's enrollment target sits among peer trials
12 1948th of 2000 higher than 34 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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