Study to Assess the Effect of Long-term Treatment With Voxelotor in Participants Who Have Completed Treatment in Study GBT440-031
Megadott ok: 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.
Key facts
- Where
- Atlanta, Baltimore, Baton Rouge, Boston, Chapel Hill, Charleston, Chicago, Detroit, Durham, Houston, Indianapolis, Little Rock, Memphis, Miami, New Orleans, New York, Newark, Oakland, Oklahoma City, Philadelphia, Pittsburgh, Richmond és The Bronx, Egyesült ÁllamokSee the 34 sites
- Phase
- 3. fázis
Where in Egyesült Államok
- Children's Healthcare of Atlanta, Scottish RiteAtlanta, Egyesült ÁllamokNo longer taking part
- Johns Hopkins University/Sickle Cell Infusion CenterBaltimore, Egyesült ÁllamokNo longer taking part
- Our Lady of the Lake Physician Group-Medical OncologyBaton Rouge, Egyesült ÁllamokNo longer taking part
- St. Jude Affiliate Clinic Baton RougeBaton Rouge, Egyesült ÁllamokNo longer taking part
- Brigham and Women's HospitalBoston, Egyesült ÁllamokNo longer taking part
- Brigham and Women's Hospital Research PharmacyBoston, Egyesült ÁllamokNo longer taking part
- Dana-Farber Cancer InstituteBoston, Egyesült ÁllamokNo longer taking part
- Clinical and Translational Research Center (CTRC)Chapel Hill, Egyesült ÁllamokNo longer taking part
- UNC HospitalsChapel Hill, Egyesült ÁllamokNo longer taking part
- Medical University of South Carolina - Comprehensive Sickle Cell ClinicCharleston, Egyesült ÁllamokNo longer taking part
- Medical University of South Carolina: Investigational Drug Services PharmacyCharleston, Egyesült ÁllamokNo longer taking part
- University of Illinois at Chicago Clinical Research CenterChicago, Egyesült ÁllamokNo longer taking part
- University of Illinois Hospital and Health Science SystemChicago, Egyesült ÁllamokNo longer taking part
- Children's Hospital of MichiganDetroit, Egyesült ÁllamokNo longer taking part
- Duke University Medical CenterDurham, Egyesült ÁllamokNo longer taking part
- Investigational Drug Service, Duke University HospitalDurham, Egyesült ÁllamokNo longer taking part
- Texas Children's HospitalHouston, Egyesült ÁllamokNo longer taking part
- Texas Children's Hospital - Investigational PharmacyHouston, Egyesült ÁllamokNo longer taking part
- Indiana Hemophilia and Thrombosis CenterIndianapolis, Egyesült ÁllamokNo longer taking part
- Arkansas Primary Care Clinic, PALittle Rock, Egyesült ÁllamokNo longer taking part
- Methodist Comprehensive Sickle Cell ClinicMemphis, Egyesült ÁllamokNo longer taking part
- Jackson Memorial HospitalMiami, Egyesült ÁllamokNo longer taking part
- Jackson Memorial Hospital (Investigational Drug Services)Miami, Egyesült ÁllamokNo longer taking part
- University of MiamiMiami, Egyesült ÁllamokNo longer taking part
- University of Miami Hospital & Clinics/SCCC, Research Pharmacy (Investigational Drug Services)Miami, Egyesült ÁllamokNo longer taking part
- University Medical Center New OrleansNew Orleans, Egyesült ÁllamokNo longer taking part
- Columbia University Medical Center - Herbert Irving PavilionNew York, Egyesült ÁllamokNo longer taking part
- Newark Beth Israel Medical CenterNewark, Egyesült ÁllamokNo longer taking part
- UCSF Benioff Children's Hospital OaklandOakland, Egyesült ÁllamokNo longer taking part
- Lynn Health Science InstituteOklahoma City, Egyesült ÁllamokNo longer taking part
- Thomas Jefferson UniversityPhiladelphia, Egyesült ÁllamokNo longer taking part
- University of Pittsburgh Medical Center (UPMC)Pittsburgh, Egyesült ÁllamokNo longer taking part
- Clinical Research Services Unit- Virginia Commonwealth UniversityRichmond, Egyesült ÁllamokNo longer taking part
- Montefiore Einstein Center for Cancer CareThe Bronx, Egyesült ÁllamokNo longer taking part
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT03573882
- Record updated
- 2025. november 18.
- Original description
Open Label Extension Study of Voxelotor Clinical Trial Participants with Sickle Cell Disease Who Participated in Voxelotor Clinical TrialsRead full original descriptionShow less
An Open Label Extension Study of Voxelotor (GBT440) Administered Orally to Participants With Sickle Cell Disease Who Have Participated in Voxelotor Clinical Trials
Open Label Extension Study of Voxelotor Clinical Trial Participants with Sickle Cell Disease Who Participated in Voxelotor Clinical Trials
Inclusion: 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: 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; 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.