Pediatric Open-Label Extension of Voxelotor
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Sickle Cell Disease
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Open-Label Extension study available to eligible participants from GBT-sponsored voxelotor pediatric clinical studies.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 4 years and 18 years
- Gender
- Both males and females
Description
Open-label extension (OLE) study of voxelotor for pediatric participants with Sickle Cell Disease who have participated in voxelotor clinical trials. Approximately 50 participants with sickle cell disease (SCD), aged ? 4 to ? 18 years will be enrolled at approximately 19 global clinical sites. All p...
Open-label extension (OLE) study of voxelotor for pediatric participants with Sickle Cell Disease who have participated in voxelotor clinical trials. Approximately 50 participants with sickle cell disease (SCD), aged ? 4 to ? 18 years will be enrolled at approximately 19 global clinical sites. All participants will receive voxelotor once daily, administered orally as tablets, dispersible tablets, or powder for oral suspension formulation. The objective of this OLE is to assess the safety of, and SCD-related complications of, long-term treatment with voxelotor, in pediatric participants who have completed treatment in a Global Blood Therapeutics (GBT)-sponsored voxelotor pediatric clinical study.
Tracking Information
- NCT #
- NCT04188509
- Collaborators
- Not Provided
- Investigators
- Study Director: Margaret Tonda, PharmD Global Blood Therapeutics, Inc.
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