Status:
ACTIVE_NOT_RECRUITING
A Phase 2/3 Study in Adult and Pediatric Participants With SCD
Lead Sponsor:
Pfizer
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
6+ years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
Detailed Description
This is a three-part, multicenter, Phase 2/3 study of orally administered osivelotor in participants with sickle cell disease (SCD). Part A will evaluate the safety, tolerability, and efficacy of osi...
Eligibility Criteria
Inclusion
- Part A, Part B, and Part C:
- Male or female with SCD
- Participants with stable Hb value as judged by the Investigator
- For participants taking hydroxyurea and/or L-glutamine, the dose must be stable for at least 90 days prior to signing the ICF or assent and with no anticipated need for dose adjustments during the study in the opinion of the Investigator.
- Part B:
- Participants with SCD ages 12 to 65 years, inclusive
- Participants with more than or equal to 2 and ≤ 10 VOCs within 12 months of Screening.
Exclusion
- Part A, Part B, and Part C:
- Participants who had more than 10 VOC within 12 months of screening
- Female participant who is breastfeeding or pregnant
- Participants who receive RBC transfusion therapy regularly or received an RBC transfusion ---for any reason within 90 days of Day 1
- Participants hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF
Key Trial Info
Start Date :
September 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2032
Estimated Enrollment :
429 Patients enrolled
Trial Details
Trial ID
NCT05431088
Start Date
September 22 2022
End Date
December 30 2032
Last Update
June 17 2025
Active Locations (24)
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1
Smilow Cancer Hospital
New Haven, Connecticut, United States, 06511
2
Children's National Hospital
Washington D.C., District of Columbia, United States, 20010
3
Edward Jenner Research Group Center LLC
Plantation, Florida, United States, 33317
4
Pediatric Hematology / Oncology a division of Kidz Medical services
West Palm Beach, Florida, United States, 33407