Trial · NCT04624659
A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
NCT04624659, Phase 3, Active not recruiting, Forma Therapeutics, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS). Trials, record NCT04624659. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04624659
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
- NCT number
- NCT04624659
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 450 participants, estimated
- Lead sponsor
- Forma Therapeutics, Inc.
- Conditions
- Sickle Cell Disease
- Interventions
- Etavopivat Tablets Low dose, Etavopivat Tablets High dose, Placebo Tablets, Etavopivat Tablets
- First posted
- 2020-11-12
- Last updated
- 2026-04-06
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hemoglobin response rate | 24 Weeks | Hemoglobin response rate at Week 24 (increase of \> 1 g/dL \[\> 10 g/L\] from baseline) during the blinded treatment period |
| Primary | Annualized vaso-occlusive crisis | 52 Weeks | Annualized vaso-occlusive crisis rate during the 52-week blinded treatment period based on adjudicated vaso-occlusive crisis review |
| Secondary | Hemoglobin | 52 Weeks | Change from baseline in hemoglobin at Week 52 during the blinded treatment period |
| Secondary | Absolute reticulocyte count | 24 Weeks | Change in absolute reticulocyte count from baseline at Week 24 during the blinded treatment period |
| Secondary | Indirect bilirubin | 24 Weeks | Change in unconjugated bilirubin from baseline at Week 24 during the blinded treatment period |
| Secondary | Lactate dehydrogenase | 24 Weeks | Change in lactate dehydrogenase from baseline at Week 24 during the blinded treatment period |
| Secondary | Vaso-occlusive crisis | 52 Weeks | Time to first vaso-occlusive crisis during the blinded treatment period |
| Secondary | Fatigue | 52 Weeks | Change in Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Scale from baseline in adult patients at Week 52 during the blinded treatment period |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04624659
GET https://conductscience.org/api/trials/v1/NCT04624659/registered