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NCT04218084 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate the Effect of GBT440 on TCD in Pediatrics With Sickle Cell Disease
A Phase 3 study, sponsored by Pfizer.
- Terminated
- Registry status
- Phase 3
- Development phase
- 236
- Enrollment target
NCT04218084: Clinical Trial Phase 3 study, sponsored by Pfizer.
NCT04218084 is a Phase 3 study that was terminated before completion, run by Pfizer. The registered enrollment target is 236 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04218084, a Phase 3 study, was terminated before completion, sponsored by Pfizer.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 236 participants
- Enrollment target
Study 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.
Primary Outcome
TAMMV is an ultrasound measurement used in transcranial Doppler (TCD) to assess blood flow in cerebral arteries. TCD flow velocities were categorized as follows: (i) Normal: \< 170 centimeter per second (cm/sec); (ii) Conditional: 170 to \< 200 cm/sec - the eligible participant population for this study; (iii) Abnormal: \>= 200 cm/sec.
Interventions
- DRUG Placebo
- DRUG Voxelotor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 236 participants |
| Start Date | 2020-11-11 |
| Est. Completion | 2024-11-06 |
| Phase | Phase 3 |
Why NCT04218084 stopped before completion
NCT04218084 is an interventional study that assigns participants to a tested intervention. The registered 236 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (69% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04218084 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04218084 about?
NCT04218084 is a clinical study titled "Study to Evaluate the Effect of GBT440 on TCD in Pediatrics With Sickle Cell Disease". 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 par...
What is the current status of trial NCT04218084?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 236 participants. The study started on 2020-11-11. Estimated completion is 2024-11-06.
What interventions are being tested in trial NCT04218084?
The interventions under investigation include: Placebo (DRUG), Voxelotor (DRUG).
Who is sponsoring clinical trial NCT04218084?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04218084's enrollment target sits among peer trials
236 1294th of 2000 higher than 705 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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