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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Forma Therapeutics, Inc.
Study ID
NCT04624659
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Jan 29, 2021
Status verified
Mar 2026
Primary completion
Feb 6, 2026
Completion
Mar 19, 2027

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Double blind etavopivat Low Dose
    Double blind etavopivat Low Dose
  • Experimental: Double blind etavopivat High Dose
    Double blind etavopivat High Dose
  • Experimental: Double blind placebo
    Double blind placebo
  • Experimental: Open label etavopivat
    Open label etavopivat

Primary Outcome Measure

Hemoglobin response rate [ Time Frame: 24 Weeks ]

Locations (63)

FacilityCityStateZIPSite coordinators
Univ of Alabama BirminghamBirminghamAlabama35233-
Phoenix Children's HsptlPhoenixArizona85016-
[Legal] Woodland International Research Group, LLCLittle RockArkansas72211-
[Legal] Collaborative Neuroscience Network, LLCLong BeachCalifornia90806-
Pacific Research PartnersOaklandCalifornia94607-
UCSF Oakland Benioff ChildHospOaklandCalifornia94609-
University Of California IrvineOrangeCalifornia92868-
UC Davis Medical CenterSacramentoCalifornia95817-
University of ConnecticutFarmingtonConnecticut06030-
Yale UniversityNew HavenConnecticut06519-
Children's National Health HospitalWashington D.C.District of Columbia20010-
Howard UniversityWashington D.C.District of Columbia20060-
Cornerstone Research InstituteAltamonte SpringsFlorida32701-
University of FloridaGainesvilleFlorida32610-
Foundation for Sickle Cell Disease ResearchHollywoodFlorida33023-
Advanced Pharma CRMiamiFlorida33147-
University Of MiamiMiamiFlorida33136-
Arnold Palmer Children's HospitalOrlandoFlorida32806-
Children's Healthcare of Atlanta Investigational Medication PharmacyAtlantaGeorgia30342-
Emory University School of MedicineAtlantaGeorgia30303-
Sonar Clinical ResearchAtlantaGeorgia30315-
Center for Blood Disorders Augusta UniversityAugustaGeorgia30912-
iResearch Atlanta, LLCDecaturGeorgia30030-
University of Illinois at ChicagoChicagoIllinois60612-
Children's Hosp-New OrleansNew OrleansLouisiana70118-
University Of Maryland School of MedicineBaltimoreMaryland21201-
Boston Medical CenterBostonMassachusetts02118-
Massachusetts General Hospital_BostonBostonMassachusetts02114-
[Legal] Dr. Vince Clinical Research, LLC and Dr. Vince Clinical Research, P.A.DetroitMichigan48201-
Karmanos Cancer InstituteDetroitMichigan48201-
Washington University School of Medicine_St. LouisSt LouisMissouri63110-
University of Nebraska Medical CenterOmahaNebraska68198-2168-
NYC Health+HospitalsBrooklynNew York11203-
Queens Hospital CenterJamaicaNew York11432-1121-
North Shore Long Island Jewish Medical CenterNew Hyde ParkNew York11040-
Columbia University Medical Center_New YorkNew YorkNew York10032-
Weill Cornell Med Coll-NYPHNew YorkNew York10065-
Jacobi Medical CenterThe BronxNew York10461-
Montefiore Medical CenterThe BronxNew York10467-
[Legal] The University of North Carolina at Chapel HillChapel HillNorth Carolina27514-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Duke University Medical CenterDurhamNorth Carolina27710-
East Carolina UniversityGreenvilleNorth Carolina27858-
Wake Forest Baptist HealthWinston-SalemNorth Carolina27157-
[Legal] Children's Hospital Medical Center dba Cincinnati Children'sCincinnatiOhio45229-
University of CincinnatiCincinnatiOhio45219-
The Ohio State University Medical CenterColumbusOhio43203-
Neuro-Behavioral Clinical ResearchNorth CantonOhio44720-
Jimmy Everest Cancer Hematology & OncologyOklahoma CityOklahoma73104-
Lynn Institute of TulsaTulsaOklahoma74135-
Children's Hosptl PhiladelphiaPhiladelphiaPennsylvania19104-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of Pittsburgh Medical CenterPittsburghPennsylvania15213-4306-
Rhode Island HospitalProvidenceRhode Island02903-
Medical University of South CarolinaCharlestonSouth Carolina29425-
Prisma Health-UpstateGreenvilleSouth Carolina29605-
[Legal] St. Jude Children's Research HospitalMemphisTennessee38105-
Methodist University HospitalMemphisTennessee38104-
[Legal] Baylor College of MedicineHoustonTexas77030-
UT Health University of TexasHoustonTexas77030-
Virginia Commonwealth UniversityRichmondVirginia23298-
Mary Bridge Children's HealthTacomaWashington98405-
Versiti Blood Center of WisconsinMilwaukeeWisconsin53226-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By condition
Sickle cell disease
By research site
Univ of Alabama Birmingham· Birmingham, ALPhoenix Children's Hsptl· Phoenix, AZ[Legal] Woodland International Research Group, LLC· Little Rock, AR[Legal] Collaborative Neuroscience Network, LLC· Long Beach, CAPacific Research Partners· Oakland, CAUCSF Oakland Benioff ChildHosp· Oakland, CA

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