Pediatric Open-Label Extension of Voxelotor

• Status: Enrolling by invitation
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Open-label extension study of voxelotor for pediatric participants ages 4 to 18 years old with Sickle Cell Disease who have participated in voxelotor clinical trials.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Global Blood Therapeutics

Criteria

Inclusion Criteria:

• Male or female participant with SCD, aged ≥ 4 to ≤ 18 years, who participated and received study drug in a GBT-sponsored voxelotor pediatric clinical study

• Participant has provided written assent (both the consent of the participant's legal representative or legal guardian and the participant's assent [where applicable] must be obtained)

Exclusion Criteria:

• Female participant who is breastfeeding or pregnant

• Participant withdrew consent from a GBT-sponsored voxelotor pediatric clinical study