A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease

Sex: All

Ages: 6 Months – 18 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 95

Sponsor: Forma Therapeutics, Inc.

Summary

The purpose of this study is to evaluate the pharmacokinetics and safety of etavopivat in paediatric participants with sickle cell disease (SCD). Participants will receive etavopivat and will be enrolled in a staggered manner, starting with the oldest age group and followed sequentially by younger cohorts after review of pharmacokinetic and safety data from the preceding cohort. All participants will undergo a 24-week primary treatment period followed by a 72-week extension treatment period to further evaluate long-term safety and pharmacokinetics of etavopivat. The total duration of the study will be approximately 96 weeks.

Eligibility Criteria

Inclusion Criteria: * Type of Participant and Disease Characteristics 1. Patient's parent, legal guardian, or legal representative has provided documented informed consent and patients have provided age-appropriate assent 2. Age greater than or equal to (≥) 6 months and lesser than (\

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06198712). StuddyBuddy aggregates publicly available trial information.