St. Mary's Medical Center | West Palm Beach - Neurology Department
Status and phase
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About
The purpose of this study is to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of osivelotor.
Full 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 osivelotor in adult participants with SCD to determine an optimal dose.
Part B will evaluate the efficacy of osivelotor versus placebo in adult and adolescent participants with SCD for 48 weeks.
Part C will evaluate the pharmacokinetics (PK) and safety of single and multiple doses (MD) of open-label single arm osivelotor administered to pediatric participants.
Enrollment
Sex
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Inclusion criteria
Part A, Part B, and Part C:
Part B:
Exclusion criteria
Part A, Part B, and Part C:
Primary purpose
Allocation
Interventional model
Masking
517 participants in 3 patient groups, including a placebo group
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Central trial contact
Pfizer Pfizer CT.gov Call Center
Data sourced from clinicaltrials.gov
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