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NCT04624659 · ClinicalTrials.gov registry record · Phase 3
A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
A Phase 3 study of Sickle Cell Disease, sponsored by Forma Therapeutics.
- Active
- Registry status
- Phase 3
- Development phase
- 450
- Enrollment target
- 20
- Study locations
NCT04624659: Active Phase 3 study of Sickle Cell Disease, sponsored by Forma Therapeutics.
NCT04624659 is a Phase 3 study of Sickle Cell Disease that is active but no longer recruiting, run by Forma Therapeutics. The registered enrollment target is 450 participants, above the 291-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (55% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04624659, a Phase 3 study of Sickle Cell Disease, is active but no longer recruiting, sponsored by Forma Therapeutics.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 450 participants
- Enrollment target
- 20
- Study locations
Study Summary
This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of etavopivat and test how well etavopivat works compared to placebo to improve the amount of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when the blood vessels become blocked and cause pain).
Primary Outcome
Hemoglobin response rate at Week 24 (increase of \> 1 g/dL \[\> 10 g/L\] from baseline) during the blinded treatment period
Conditions Studied
Interventions
- DRUG Placebo Tablets
- DRUG Etavopivat Tablets Low dose
- DRUG Etavopivat Tablets High dose
- DRUG Etavopivat Tablets
Study Locations (20)
Florida
- Cornerstone Research Institute - Altamonte Springs
- University of Florida - Gainesville
- Foundation for Sickle Cell Disease Research - Hollywood
- University Of Miami - Miami
- Advanced Pharma CR - Miami
- Arnold Palmer Children's Hospital - Orlando
California
- [Legal] Collaborative Neuroscience Network, LLC - Long Beach
- Pacific Research Partners - Oakland
- UCSF Oakland Benioff ChildHosp - Oakland
- University Of California Irvine - Orange
- UC Davis Medical Center - Sacramento
Georgia
- Emory University School of Medicine - Atlanta
- Sonar Clinical Research - Atlanta
- Children's Healthcare of Atlanta Investigational Medication Pharmacy - Atlanta
Connecticut
- University of Connecticut - Farmington
- Yale University - New Haven
Alabama
- Univ of Alabama Birmingham - Birmingham
Arizona
- Phoenix Children's Hsptl - Phoenix
Arkansas
- [Legal] Woodland International Research Group, LLC - Little Rock
District of Columbia
- Howard University - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 450 participants |
| Start Date | 2021-01-29 |
| Est. Completion | 2027-03-19 |
| Phase | Phase 3 |
What the registry record for NCT04624659 still lists
NCT04624659 is an interventional study that assigns participants to a tested intervention. The registered 450 participants enrollment target is mid-sized for trials with a published cap, above the 291-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (55% higher).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 4 interventions - of which Placebo Tablets is the first listed.
NCT04624659 names 20 study sites across 8 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT04624659 about?
NCT04624659 is a clinical study titled "A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)". This clinical trial is a Phase 2/3 study that will evaluate the efficacy and safety of etavopivat and test how well etavopivat works compared to placebo to improve the amount of hemoglobin in the blood and to reduce the number of vaso-occlusive crises (times when the blood vessels become blocked and...
What is the current status of trial NCT04624659?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 450 participants. The study started on 2021-01-29. Estimated completion is 2027-03-19.
What conditions does trial NCT04624659 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT04624659?
The interventions under investigation include: Placebo Tablets (DRUG), Etavopivat Tablets Low dose (DRUG), Etavopivat Tablets High dose (DRUG), Etavopivat Tablets (DRUG).
Who is sponsoring clinical trial NCT04624659?
This trial is sponsored by Forma Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04624659 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04624659's enrollment target sits among peer trials
450 10th of 213 higher than 204 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease 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.
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