A Study to Evaluate How Well Etavopivat Works in People With Sickle Cell Disease

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Novo Nordisk A/S
Study ID
NCT06612268
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Etavopivat — DRUG
    Etavopivat will be administered orally.
  • Placebo — DRUG
    Placebo matching Etavopivat will be administered orally.

Study Details

This study is conducted to confirm whether etavopivat works well at reducing the number of Vaso-occlusive crisis VOCs (sickle cell pain crises) caused by obstructions in blood vessels in adults and adolescents living with sickle cell disease. The study will also evaluate how well etavopivat can reduce the damage to different organs, improve your exercise tolerance and reduce fatigue in people with sickle cell disease.The participants will either get etavopivat or placebo. Which treatment the participants will get is decided by chance. Etavopivat is a new medicine and is currently being tested in other studies in addition to this one. The study will last for about 2 years.

Key Dates

Start date
Feb 17, 2025
Status verified
Apr 2026
Primary completion
Aug 27, 2027
Completion
Mar 12, 2029

Study Design

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

Arms

  • Experimental: Etavopivat
    Participants will be randomised to receive oral dose of Etavopivat.
  • Placebo Comparator: Placebo
    Participants will be randomised to receive oral dose of placebo.

Primary Outcome Measure

Number of adjudicated Vaso-occlusive crisis (VOC) events with a medical contact [ Time Frame: Baseline (week 0) to week 52 ]

Central Contacts

Locations (50)

FacilityCityStateZIPSite coordinators
Uni of Alabama at BirminghamBirminghamAlabama35233-
Univer South Alabama Ped/OncMobileAlabama36604-
Phoenix Children's HsptlPhoenixArizona85016-
Arkansas Children's HospitalLittle RockArkansas72202-
Children's Hospital Los Angeles - EndocrinologyLos AngelesCalifornia90027-
UCLA HealthLos AngelesCalifornia90095-
Valley Children's HospitalMaderaCalifornia93636-
University Of California IrvineOrangeCalifornia92868-
Stanford University_Palo AltoPalo AltoCalifornia94304-
Harbor-UCLA Medical CenterTorranceCalifornia90502-
Clinical and Transl Res CenterAuroraColorado80045-
Nemours/AI duPont Hosp-ChldWilmingtonDelaware19803-
Childrens National Medical CtrWashington D.C.District of Columbia20010-
MedStar Hlth Res InstituteWashington D.C.District of Columbia20010-
Memorial HealthcareHollywoodFlorida33021-
Children's Healthcare AtlantaAtlantaGeorgia30329-
Childrens Hospital of ChicagoChicagoIllinois60611-
Univer Of Illinois at ChicagoChicagoIllinois60612-
Children's Hosp-New OrleansNew OrleansLouisiana70118-
Boston Children's HospitalBostonMassachusetts02115-
Boston Medical CenterBostonMassachusetts02118-2393-
Henry Ford Hospital_DetroitDetroitMichigan48202-
University of MinnesotaMinneapolisMinnesota55455-
Washington University-St.LouisSt LouisMissouri63110-
Children's NebraskaOmahaNebraska68114-
Cure 4 the Kids FoundationLas VegasNevada89135-
Newark Beth Israel MCNewarkNew Jersey07112-2027-
Interfaith Medical CenterBrooklynNew York11238-
NYC Health+HospitalsBrooklynNew York11203-
Northwell HealthMount KiscoNew York10549-
Cohen Children's Medical CtrQueensNew York11040-
Jacobi Medical CenterThe BronxNew York10461-
Montefiore Medical CtrThe BronxNew York10467-
Duke Comprehen Sickle CellDurhamNorth Carolina27710-
Duke University Medical CenterDurhamNorth Carolina27710-
East Carolina Univ-GreenvilleGreenvilleNorth Carolina27834-
Atrium Health-Wake Forest BaptWinston-SalemNorth Carolina27157-
Univ Hosp Cleveland Med CtrClevelandOhio44106-
Ohio State Univ Wexner Med CtrColumbusOhio43203-
Univ of OK Health Sciences CtrOklahoma CityOklahoma73104-
Children's Hosptl PhiladelphiaPhiladelphiaPennsylvania19104-
St Christopher Hosp for ChildPhiladelphiaPennsylvania19134-
St. Jude Children's Res HospMemphisTennessee38105-
University of Tennessee Health Science CenterMemphisTennessee38104-
UT Health University of TexasHoustonTexas77030-
Inova Health SystemFairfaxVirginia22031-
Children's Hsptl Of The KingsNorfolkVirginia23507-
Virginia Comm Univ Medical CtrRichmondVirginia23298-
Mary Bridge Children's HealthTacomaWashington98405-
Mary Bridge Children's HealthTacomaWashington98405-

Find similar trials in Birmingham, AL

By condition
Sickle cell disease
By research site
Uni of Alabama at Birmingham· Birmingham, ALUniver South Alabama Ped/Onc· Mobile, ALPhoenix Children's Hsptl· Phoenix, AZArkansas Children's Hospital· Little Rock, ARChildren's Hospital Los Angeles - Endocrinology· Los Angeles, CAUCLA Health· Los Angeles, CA

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