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Study to Evaluate the Effect of GBT440 on TCD in Pediatrics With Sickle Cell Disease

NCT04218084 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2026-03-10

Study results available
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Summary

This study is a Phase 3, randomized, double-blind, placebo-controlled study of voxelotor in pediatric participants, aged ≥ 2 to \< 15 years old, with Sickle Cell Disease. The primary objective is to evaluate the effect of voxelotor on the TCD (Transcranial Doppler Ultrasound) measurements in SCD participants in this age range.

Conditions

Interventions

DRUG

Voxelotor

Participants are randomized 1:1 to receive voxelotor or placebo.

DRUG

Placebo

Matching placebo.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-11
Primary Completion
2024-01-18
Completion
2024-11-06
FDA Drug
Yes

Countries

  • United States
  • Egypt
  • Ghana
  • Italy
  • Kenya
  • Nigeria
  • Oman
  • Saudi Arabia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04218084 on ClinicalTrials.gov