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Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE)
Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE)

NCT03036813

CompletedPhase 3

Sponsor: Pfizer

Conditions: Sickle Cell Disease

Interventions: voxelotor, Placebo

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

A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor Administered Orally to Patients With Sickle Cell Disease

Eligibility overview

Sex: ALL

Age: 12 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

1. Male or female study participants with sickle cell disease
2. Participants have had at least 1 episode of vaso-occlusive crisis (VOC) in the past 12 months.
3. Age 12 to 65 years
4. Hemoglobin (Hb) ≥5.5 and ≤10.5 g/dL during screening
5. For participants taking hydroxyurea (HU), the dose of HU (mg/kg) must be stable for at least 3 months prior to signing the ICF.

Exclusion Criteria:

1. More than 10 VOCs within the past 12 months that required a hospital, emergency room or clinic visit
2. Patients who are receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or have received a RBC transfusion for any reason within 60 days of signing the ICF
3. Hospitalized for sickle cell crisis or other vaso-occlusive event within 14 days of signing the ICF (i.e., a vaso-occlusive event cannot be within 14 days prior to signing the ICF)
4. Hepatic dysfunction characterized by alanine aminotransferase (ALT) \>4 × upper limit of normal
5. Severe renal dysfunction (estimated glomerular filtration rate at the Screening visit; calculated by the central laboratory) \<30 mL/min/1.73 m\^2 or on chronic dialysis
Locations (62)
  • Birmingham, Alabama, United States
  • Mobile, Alabama, United States
  • Little Rock, Arkansas, United States
  • Oakland, California, United States
  • Miami, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Baton Rouge, Louisiana, United States
  • New Orleans, Louisiana, United States
  • Baltimore, Maryland, United States
  • Bethesda, Maryland, 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
  • Durham, North Carolina, United States
  • Greenville, North Carolina, United States
  • Oklahoma City, Oklahoma, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Memphis, Tennessee, United States
  • Nashville, Tennessee, United States
  • Houston, Texas, United States
  • Richmond, Virginia, United States
  • Toronto, Canada
  • + 32 more on CT.gov