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

NCT03573882

TerminatedPhase 3

Sponsor: Pfizer

Conditions: Sickle Cell Disease

Interventions: Voxelotor

Countries: United States, Canada, Egypt, France, Italy, Kenya, Lebanon, Netherlands

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

Eligibility overview

Sex: ALL

Age: 12 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Locations (60)

Little Rock, Arkansas, United States
Oakland, California, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Baton Rouge, Louisiana, United States
Baton Rouge, Louisiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Newark, New Jersey, United States
New York, New York, United States
The Bronx, New York, United States
Chapel Hill, North Carolina, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Durham, North Carolina, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
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