Study to Evaluate Rilzabrutinib in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)
Public ClinicalTrials.gov record NCT04562766. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With an Open-Label Extension to Evaluate the Efficacy and Safety of Oral Rilzabrutinib (PRN1008) in Adults and Adolescents With Persistent or Chronic Immune Thrombocytopenia (ITP)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This was a randomized, double-blind study of rilzabrutinib in patients with persistent or chronic ITP, with an average platelet count of \<30,000/μL (and no single platelet count \>35,000/μL) on two counts at least 5 days apart in the 14 days before treatment begins. Patients received rilzabrutinib or placebo 400mg twice daily. For each patient, the study lasted up to 60 weeks from the start of the Screening Period to the End of Study (EOS) visit. This included Screening (up to 4 weeks) through a 12 to 24-week Blinded Treatment Period followed by a 28-week Open-Label Period. Followed by a 4-week post dose follow-up. For adult participants, the maximum duration of the long-term extension (LTE) period was 12 months from the date of the last adult participant to enter the LTE. For pediatric participants, the maximum duration of the LTE period was 12 months from the date of the last pediatric participant to enter the LTE.
Study identification
- NCT ID
- NCT04562766
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 232 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 10 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 13, 2020
- Primary completion
- Jan 14, 2025
- Completion
- Aug 25, 2026
- Last update posted
- Feb 22, 2026
2020 – 2026
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Southern California_Investigational Site Number 84024 | Los Angeles | California | 90033 | — |
| UCSF Benioff Children's Hospital San Francisco_Investigational Site Number 84020 | San Francisco | California | 94158 | — |
| Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center_Investigational Site Number 84037 | Torrance | California | 90502 | — |
| The Oncology Institute of Hope and Innovation_Investigational Site Number 84031 | Whittier | California | 90602 | — |
| Children's Hospital Colorado_Investigational Site Number 84025 | Aurora | Colorado | 80045 | — |
| IMMUNOe International Research Centers_Investigational Site Number 84028 | Centennial | Colorado | 80112 | — |
| ASCLEPES Research Centers_Investigational Site Number 84023 | Weeki Wachee | Florida | 34607 | — |
| Children's Healthcare of Atlanta_Investigational Site Number 84034 | Atlanta | Georgia | 30322 | — |
| Rush University Medical Center_Investigational Site Number 84029 | Chicago | Illinois | 60612 | — |
| University of Louisville - James Graham Brown Cancer Center_Investigational Site Number 84033 | Louisville | Kentucky | 40202 | — |
| Massachusetts General Hospital Site Number : 84038 | Boston | Massachusetts | 02114 | — |
| Montefiore Medical Center_Investigational Site Number 84032 | The Bronx | New York | 10461 | — |
| University Hospitals Cleveland Medical Center Site Number : 84036 | Cleveland | Ohio | 44106 | — |
| Cleveland Clinic_Investigational Site Number 84026 | Cleveland | Ohio | 44195 | — |
| The Children's Hospital of Philadelphia (CHOP)_Investigational Site Number 84027 | Philadelphia | Pennsylvania | 19104 | — |
| University of Utah-Huntsman Cancer Institute_Investigational Site Number 84035 | Salt Lake City | Utah | 84112 | — |
| University of Washington Medical Centre Site Number : 84041 | Seattle | Washington | 98195 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 138 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04562766, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 22, 2026 · Synced Sep 5, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04562766 live on ClinicalTrials.gov.