Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE) (GBT_HOPE)
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ClinicalTrials.gov Identifier: NCT03036813 |
Recruitment Status :
Completed
First Posted : January 30, 2017
Results First Posted : January 7, 2021
Last Update Posted : January 7, 2021
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Sponsor:
Global Blood Therapeutics
Information provided by (Responsible Party):
Global Blood Therapeutics
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Tracking Information | |||||
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First Submitted Date ICMJE | January 27, 2017 | ||||
First Posted Date ICMJE | January 30, 2017 | ||||
Results First Submitted Date ICMJE | October 28, 2020 | ||||
Results First Posted Date ICMJE | January 7, 2021 | ||||
Last Update Posted Date | January 7, 2021 | ||||
Actual Study Start Date ICMJE | December 2016 | ||||
Actual Primary Completion Date | October 8, 2019 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Number of Participants With Increase in Hb >1 g/dL From Baseline to Week 24 [ Time Frame: Baseline to Week 24 ] Number of participants with increase in Hb >1 g/dL from Baseline to Week 24
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Original Primary Outcome Measures ICMJE |
Change in hemoglobin (Hb) [ Time Frame: Baseline to Week 24 ] Proportion of participants with increase in Hb >1 g/dL from Baseline to Week 24
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Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Study to Evaluate the Effect of Voxelotor Administered Orally to Patients With Sickle Cell Disease (GBT_HOPE) | ||||
Official Title ICMJE | A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor Administered Orally to Patients With Sickle Cell Disease | ||||
Brief Summary | A Phase 3, Double-blind, Randomized, Placebo-controlled, Multicenter Study of Voxelotor Administered Orally to Patients With Sickle Cell Disease | ||||
Detailed Description | 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 ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Investigator) Masking Description: This study is a double-blind study. Primary Purpose: Treatment
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Condition ICMJE | Sickle Cell Disease | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
449 | ||||
Original Estimated Enrollment ICMJE |
400 | ||||
Actual Study Completion Date ICMJE | October 8, 2019 | ||||
Actual Primary Completion Date | October 8, 2019 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 12 Years to 65 Years (Child, Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Canada, Egypt, France, Italy, Jamaica, Kenya, Lebanon, Netherlands, Oman, Turkey, United Kingdom, United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT03036813 | ||||
Other Study ID Numbers ICMJE | GBT440-031 | ||||
Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Global Blood Therapeutics | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Global Blood Therapeutics | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Not Provided | ||||
Investigators ICMJE |
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PRS Account | Global Blood Therapeutics | ||||
Verification Date | January 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |