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ACTIVE NOT RECRUITING Phase 3

A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)

NCT04624659 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 450 participants
Start Date 2021-01-29
Est. Completion 2027-03-19
Phase Phase 3

Sponsor

Forma Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04624659

The ClinicalTrials.gov registry entry for NCT04624659 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 450 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forma Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04624659 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Florida, California, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04624659?

This trial is sponsored by Forma Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial