drugset / Trial / NCT03573882

Study to Assess the Effect of Long-term Treatment With Voxelotor in Participants Who Have Completed Treatment in Study GBT440-031

NCT03573882 ↗

Phase 3 Terminated 179 enrolled Pfizer
NaSingle-groupOpen-labelTreatment

Summary

Open Label Extension Study of Voxelotor Clinical Trial Participants with Sickle Cell Disease Who Participated in Voxelotor Clinical Trials

Timeline

Start
2018-06-06
Primary completion
2024-11-12
Completion
2024-11-12

Outcome

Outcome not reported

Stopped: “Emerging clinical data evaluated by Pfizer and shared with regulatory authorities indicates that the risk profile of voxelotor in people with SCD exceeds the benefits observed in previously generated global research and requires further assessment.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Voxelotor Small molecule 900 mg Oral
Subject Voxelotor Small molecule 1500 mg Oral

Indications