Status:
ACTIVE_NOT_RECRUITING
A Study of Rilzabrutinib in Adult Patients With Immune Thrombocytopenia (ITP)
Lead Sponsor:
Principia Biopharma, a Sanofi Company
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief 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 plat...
Detailed Description
This was a 2 part (Part A and B) adaptive, open-label, dose-finding study of PRN1008 in approximately 60 patients in Part A and approximately 25 patients in Part B. Part A enrolled patients with ITP ...
Eligibility Criteria
Inclusion
- Male or female patients, aged 18 to 80 years old
- Immune-related ITP (both primary and secondary)
Exclusion
- Pregnant or lactating women
- Current drug or alcohol abuse
- History of solid organ transplant
- Positive screening for HIV, hepatitis B, or hepatitis C
Key Trial Info
Start Date :
March 22 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 18 2025
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT03395210
Start Date
March 22 2018
End Date
December 18 2025
Last Update
November 14 2025
Active Locations (31)
Enter a location and click search to find clinical trials sorted by distance.
1
Bleeding and Clotting Disorders Institute- Site Number : 1087
Peoria, Illinois, United States, 61614-2868
2
RCCA MC LLC- Site Number : 1091
Bethesda, Maryland, United States, 20817-1915
3
Massachusetts General Hospital Cancer Center- Site Number : 1092
Boston, Massachusetts, United States, 02114-2603
4
Beth Israel Deaconess Medical Center- Site Number : 1099
Boston, Massachusetts, United States, 02215