Trials / Terminated
TerminatedNCT05561140
Resolution of Sickle Cell Leg Ulcers With Voxelotor
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy of Voxelotor for the Treatment of Leg Ulcers in Patients With Sickle Cell Disease
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 88 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This study is a Phase 3, multicenter, randomized, placebo-controlled study to evaluate the efficacy of voxelotor and standard of care for the treatment of leg ulcers in participants with sickle cell disease. The study is divided into a 5 study periods: Screening, Run-in, Randomized Treatment, Open-label Treatment, and Follow-up/End of Study (EOS). The study will be conducted in approximately 80 eligible participants at approximately 20 global clinical trial sites.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Voxelotor Oral Tablet | Synthetic small molecule supplied as 500 mg tablets, administered Orally |
| OTHER | Placebo | Placebo |
Timeline
- Start date
- 2022-05-30
- Primary completion
- 2024-06-26
- Completion
- 2024-10-22
- First posted
- 2022-09-30
- Last updated
- 2025-07-09
- Results posted
- 2025-07-09
Locations
23 sites across 3 countries: Brazil, Kenya, Nigeria
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05561140. Inclusion in this directory is not an endorsement.