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Study to Evaluate the Effect of GBT440 in Pediatrics With Sickle Cell Disease — HOPE  

Sickle Cell Disease Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02850406
Study type Interventional
Source Pfizer
Contact
Status Active, not recruiting
Phase Phase 2
Start date July 5, 2016
Completion date December 20, 2026
View Details
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