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

Stopped early · Phase 3

Conditions studied: Sickle Cell Disease

In brief

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

Key facts

Study ID

NCT03573882

Run by

Pfizer

People needed

179

Starts

2018-06-06

Expected to finish

2024-11-12

Last updated by the study team

2025-11-18

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female study participants with SCD who participated and received study treatment in Study GBT440-031.
• Note: Participants in GBT440-031 who discontinued study drug due to an AE, but who remained on study may be eligible for treatment in this study provided the AE does not pose a risk for treatment with voxelotor.
• Females of child-bearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1.
• Female participants of child-bearing potential must use highly effective methods of contraception to 30 days after the last dose of study drug. Male participants must use barrier methods of contraception to 30 days after the last dose of study drug.
• Participant has provided written informed consent or assent (the ICF must be reviewed and signed by each participant; in the case of pediatric participants, both the consent of the participant's legal representative or legal guardian, and the participant's assent must be obtained).

You may not qualify if…

• Female who is breast-feeding or pregnant.
• Participant withdrew consent from Study GBT440-031.
• Participant was lost to follow-up from Study GBT440-031.
• Participant requiring chronic dialysis.
• Any medical, psychological, safety, or behavioral conditions, which, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent.

Where it is running

• UCSF Benioff Children's Hospital Oakland — Oakland, California, United States
• Jackson Memorial Hospital (Investigational Drug Services) — Miami, Florida, United States
• Jackson Memorial Hospital — Miami, Florida, United States
• University of Miami Hospital & Clinics/SCCC, Research Pharmacy (Investigational Drug Services) — Miami, Florida, United States
• University of Miami — Miami, Florida, United States
• Children's Healthcare of Atlanta - Scottish Rite — Atlanta, Georgia, United States
• University of Illinois at Chicago Clinical Research Center — Chicago, Illinois, United States
• University of Illinois Hospital and Health Science System — Chicago, Illinois, United States
• Indiana Hemophilia and Thrombosis Center — Indianapolis, Indiana, United States
• St. Jude Affiliate Clinic Baton Rouge — Baton Rouge, Louisiana, United States
• Our Lady of the Lake Physician Group-Medical Oncology — Baton Rouge, Louisiana, United States
• University Medical Center New Orleans — New Orleans, Louisiana, United States
• Johns Hopkins University/Sickle Cell Infusion Center — Baltimore, Maryland, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Brigham and Women's Hospital Research Pharmacy — Boston, Massachusetts, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• Children's Hospital of Michigan — Detroit, Michigan, United States
• Newark Beth Israel Medical Center — Newark, New Jersey, United States
• Columbia University Medical Center - Herbert Irving Pavilion — New York, New York, United States
• Montefiore - Einstein Center for Cancer Care — The Bronx, New York, United States
• UNC Hospitals — Chapel Hill, North Carolina, United States
• Clinical and Translational Research Center (CTRC) — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Investigational Drug Service, Duke University Hospital — Durham, North Carolina, United States
• Arkansas Primary Care Clinic, PA — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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