Expanded Access Protocol for Adults and Pediatric Patients With Sickle Cell Disease Who Have No Alternative Treatment Options

NO_LONGER_AVAILABLE

Conditions studied: Sickle Cell Disease

In brief

The objective of this Expanded Access Protocol (EAP) is to provide voxelotor for the treatment of sickle cell disease (SCD): The study GBT440-041 is the EAP for pediatric patients aged 6 months to 11 years who have no alternative treatment options and are ineligible to participate in a clinical trial of voxelotor and the study C5341057 is the EAP for adults/adolescents 12 years of age and older for patients who cannot satisfactorily be treated with an authorized medicinal product

Key facts

Study ID

NCT04724421

Run by

Pfizer

Last updated by the study team

2024-11-20

Who can join

Age: 1 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• Nemours/Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Hospital / Children's National Health System — Washington D.C., District of Columbia, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Baptist Medical Center/Wolfson Children's Hospital — Jacksonville, Florida, United States
• Nemours Children's Health, Jacksonville — Jacksonville, Florida, United States
• Nemours Children's Hospital — Orlando, Florida, United States
• Children's Healthcare of Atlanta Scottish Rite — Atlanta, Georgia, United States
• AU Medical Center Clinical Research Pharmacy — Augusta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• Children's Hospital of Georgia — Augusta, Georgia, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• Tulane Lakeside — Metairie, Louisiana, United States
• Tulane University Hospitals and Clinics — New Orleans, Louisiana, United States
• Children's Hospital — New Orleans, Louisiana, United States
• Childrens Hospital of NOLA — New Orleans, Louisiana, United States
• University Of Michigan Hospitals — Ann Arbor, Michigan, United States
• Rutgers Cancer Institute of New Jersey — New Brunswick, New Jersey, United States
• Newark Beth Israel Medical Center & Children's Hospital of New Jersey — Newark, New Jersey, United States
• BronxCare Health System — The Bronx, New York, United States
• Jacobi Medical Center — The Bronx, New York, United States
• East Carolina University Brody School of Medicine(ECU) — Greenville, North Carolina, United States
• ECU Physicians, Brody Outpatient Clinic — Greenville, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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