Study to Evaluate the Effect of GBT440 in Pediatrics With Sickle Cell Disease
Public ClinicalTrials.gov record NCT02850406. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2a, Open-label, Single and Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, Tolerability and Treatment Effect of GBT440 in Pediatric Participants With Sickle Cell Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study consists of four parts, Parts A, B, C, and D. * Part A is a single dose pharmacokinetic (PK) study in pediatric participants with Sickle Cell Disease ages 6 to 17 years. * Part B is a multiple dose, safety, exploratory, efficacy, and PK study in adolescent participants with Sickle Cell Disease ages 12 to 17 years. * Part C is a multiple dose, safety, tolerability, and PK study, which includes the assessment of hematological effects and the effect on TCD flow velocity of voxelotor in pediatric participants with Sickle Cell Disease ages 4 to 17 years. * Part D is a multiple dose, safety, tolerability, and PK study, which examines the hematological effects of voxelotor in pediatric participants with Sickle Cell Disease ages 6 months to \< 4 years.
Study identification
- NCT ID
- NCT02850406
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 147 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 6 Months to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 4, 2016
- Primary completion
- Oct 1, 2023
- Completion
- Oct 1, 2023
- Last update posted
- Aug 14, 2025
2016 – 2023
United States locations
- U.S. sites
- 13
- U.S. states
- 11
- U.S. cities
- 12
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Brentwood Clinic UCSF Benioff Children's Hospital Oakland | Brentwood | California | 94513 | — |
| Children's National Medical Center | Washington D.C. | District of Columbia | 20010 | — |
| Children's Healthcare of Atlanta Scottish Rite | Atlanta | Georgia | 30342 | — |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | — |
| University of Illinois at Chicago Clinical Research Center | Chicago | Illinois | 60612 | — |
| Our Lady of the Lake Children's Hospital (IP Address) | Baton Rouge | Louisiana | 70809 | — |
| Children's Mercy Hospital | Kansas City | Missouri | 64108 | — |
| Rutgers-Robert Wood Johnson Medical School | New Brunswick | New Jersey | 08903 | — |
| Brody School of Medicine at East Carolina University | Greenville | North Carolina | 27834 | — |
| University Hospitals Cleveland Medical Center, Rainbow Babies & Children's Hospital | Cleveland | Ohio | 44106 | — |
| The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | — |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 7 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02850406, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 14, 2025 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02850406 live on ClinicalTrials.gov.