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NCT03395210 · ClinicalTrials.gov registry record · Phase 2
A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)
A Phase 2 study, sponsored by Principia Biopharma, a Sanofi Company.
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
NCT03395210 is a Phase 2 study that has completed, run by Principia Biopharma, a Sanofi Company. The registered enrollment target is 86 participants.
The verdict
NCT03395210, a Phase 2 study, has completed, sponsored by Principia Biopharma, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
Study Summary
This was a 2 part (Part A and B) adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count \<30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment begins. The dose-finding portion of the study was completed. Part B treatment dose was 400 mg twice daily.
Interventions
- DRUG Rilzabrutinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2018-03-22 |
| Est. Completion | 2025-12-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03395210
The ClinicalTrials.gov registry entry for NCT03395210 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Principia Biopharma, a Sanofi Company, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Rilzabrutinib is the first listed.
NCT03395210 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03395210 about?
NCT03395210 is a clinical study titled "A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)". This was a 2 part (Part A and B) adaptive, open-label, dose-finding study of PRN1008 in patients with ITP who are refractory or relapsed with no available and approved therapeutic options, with a platelet count \<30,000/μL on two counts no sooner than 7 days apart in the 15 days before treatment beg...
What is the current status of trial NCT03395210?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2018-03-22. Estimated completion is 2025-12-11.
What interventions are being tested in trial NCT03395210?
The interventions under investigation include: Rilzabrutinib (DRUG).
Who is sponsoring clinical trial NCT03395210?
This trial is sponsored by Principia Biopharma, a Sanofi Company, which has 8 total clinical trials registered on ClinicalTrials.gov.
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