A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor Administered Orally to Patients With Sickle Cell Disease
This is a randomized, placebo-controlled, double blind, parallel group, multicenter study of participants, age 12 to 65 years, with SCD. The key purpose for the study is to establish efficacy and safety of voxelotor as compared with placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
449
Number of Participants With Increase in Hb >1 g/dL From Baseline to Week 24
Number of participants with increase in Hb \>1 g/dL from Baseline to Week 24
Time frame: Baseline to Week 24
Annualized Vaso-Occlusive Crisis (VOC) Incidence Rate
Number of Vaso-Occlusive Crisis (VOC) events averaged per year.
Time frame: Baseline to Week 72
Percentage Change From Baseline in Hemolysis Measures
Percentage change from Baseline to week 24 in unconjugated bilirubin
Time frame: Baseline to Week 24
Percentage Change From Baseline in Hemolysis Measures
Percentage change from Baseline to week 24 in the absolute reticulocyte which is used to estimate the degree of effective erythropoiesis. This values is important in Sickle Cell Disease and was reported by the central laboratory.
Time frame: Baseline to Week 24
Percentage Change From Baseline in Hemolysis Measures
Percentage change from Baseline to week 24 in reticulocytes % which is a % of total Red Blood Cells (RBCs).
Time frame: Baseline to Week 24
Percentage Change From Baseline in Hemolysis Measures
Percentage change from Baseline to week 24 in Lactate Dehydrogenase (LDH)
Time frame: Baseline to Week 24
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Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Little Rock, Arkansas, United States
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Oakland, California, United States
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Miami, Florida, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Baton Rouge, Louisiana, United States
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New Orleans, Louisiana, United States
...and 52 more locations