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ACTIVE NOT RECRUITING
NCT04624659
PHASE3

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

Sponsor: Forma Therapeutics, Inc.

View on ClinicalTrials.gov

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).

Official title: An Adaptive, Randomized, Placebo-controlled, Double-blind, Multi-center Study of Oral Etavopivat, a Pyruvate Kinase Activator in Patients With Sickle Cell Disease (HIBISCUS)

Key Details

Gender

All

Age Range

12 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2021-01-29

Completion Date

2027-03-19

Last Updated

2026-04-06

Healthy Volunteers

No

Interventions

DRUG

Etavopivat Tablets Low dose

200 mg once daily

DRUG

Etavopivat Tablets High dose

400 mg once daily

DRUG

Placebo Tablets

Placebo once daily

DRUG

Etavopivat Tablets

Selected dose once daily

Locations (142)

Univ of Alabama Birmingham

Birmingham, Alabama, United States

Phoenix Children's Hsptl

Phoenix, Arizona, United States

[Legal] Woodland International Research Group, LLC

Little Rock, Arkansas, United States

[Legal] Collaborative Neuroscience Network, LLC

Long Beach, California, United States

Pacific Research Partners

Oakland, California, United States

UCSF Oakland Benioff ChildHosp

Oakland, California, United States

University Of California Irvine

Orange, California, United States

UC Davis Medical Center

Sacramento, California, United States

University of Connecticut

Farmington, Connecticut, United States

Yale University

New Haven, Connecticut, United States

Children's National Health Hospital

Washington D.C., District of Columbia, United States

Howard University

Washington D.C., District of Columbia, United States

Cornerstone Research Institute

Altamonte Springs, Florida, United States

University of Florida

Gainesville, Florida, United States

Foundation for Sickle Cell Disease Research

Hollywood, Florida, United States

University Of Miami

Miami, Florida, United States

Advanced Pharma CR

Miami, Florida, United States

Arnold Palmer Children's Hospital

Orlando, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

Sonar Clinical Research

Atlanta, Georgia, United States

Children's Healthcare of Atlanta Investigational Medication Pharmacy

Atlanta, Georgia, United States

Center for Blood Disorders Augusta University

Augusta, Georgia, United States

iResearch Atlanta, LLC

Decatur, Georgia, United States

University of Illinois at Chicago

Chicago, Illinois, United States

Children's Hosp-New Orleans

New Orleans, Louisiana, United States

University Of Maryland School of Medicine

Baltimore, Maryland, United States

Massachusetts General Hospital_Boston

Boston, Massachusetts, United States

Boston Medical Center

Boston, Massachusetts, United States

[Legal] Dr. Vince Clinical Research, LLC and Dr. Vince Clinical Research, P.A.

Detroit, Michigan, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

Washington University School of Medicine_St. Louis

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

NYC Health+Hospitals

Brooklyn, New York, United States

Queens Hospital Center

Jamaica, New York, United States

North Shore Long Island Jewish Medical Center

New Hyde Park, New York, United States

Columbia University Medical Center_New York

New York, New York, United States

Weill Cornell Med Coll-NYPH

New York, New York, United States

Jacobi Medical Center

The Bronx, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

[Legal] The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Levine Cancer Institute

Charlotte, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

East Carolina University

Greenville, North Carolina, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

University of Cincinnati

Cincinnati, Ohio, United States

[Legal] Children's Hospital Medical Center dba Cincinnati Children's

Cincinnati, Ohio, United States

The Ohio State University Medical Center

Columbus, Ohio, United States

Neuro-Behavioral Clinical Research

North Canton, Ohio, United States

Jimmy Everest Cancer Hematology & Oncology

Oklahoma City, Oklahoma, United States

Lynn Institute of Tulsa

Tulsa, Oklahoma, United States

Children's Hosptl Philadelphia

Philadelphia, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Medical University of South Carolina

Charleston, South Carolina, United States

Prisma Health-Upstate

Greenville, South Carolina, United States

Methodist University Hospital

Memphis, Tennessee, United States

[Legal] St. Jude Children's Research Hospital

Memphis, Tennessee, United States

[Legal] Baylor College of Medicine

Houston, Texas, United States

UT Health University of Texas

Houston, Texas, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Mary Bridge Children's Health

Tacoma, Washington, United States

Versiti Blood Center of Wisconsin

Milwaukee, Wisconsin, United States

Providence Hematolgy

Vancouver, British Columbia, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

CHU Sainte-Justine Mother and Child University Hospital

Montreal, Quebec, Canada

[Legal] Alexandria Clinical Research LLC

Alexandria, Egypt

[Legal] Alexandria Clinical Research LLC

Alexandria, Egypt

Cairo University

Cairo, Egypt

Ain Shams University Hospital

Cairo, Egypt

Al Kasr AL Aini Hospital

Cairo, Egypt

Sydnawy University Hospital

Zagazig, Egypt

Ap-Hp-Hopital Henri Mondor

Créteil, France

Hospices Civils de Lyon-Hopital Edouard Herriot

Lyon, France

Centre Hospitalier Universitaire de Montpellier-Hopital Saint-Eloi

Montpellier, France

GHR Mulhouse Sud-Alsace

Mulhouse, France

Ap-Hp-Hopital Robert Debre

Paris, France

Saint-Denis Hospital Center

Saint-Denis, France

Charité - Campus Virchow-Klinikum - Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie

Berlin, Germany

Universitätsklinikum Frankfurt

Frankfurt am Main, Germany

Universitätsklinikum Freiburg-Zentrum für Kinder- und Jugendmedizin

Freiburg im Breisgau, Germany

Universitätsklinikum Hamburg-Eppendorf - University Medical Center Hamburg-Eppendorf

Hamburg, Germany

Uniklinik Heidelberg - Klinik für Pädiatrische Onkologie, Hämatologie, Immunologie und Pneumologie

Heidelberg, Germany

Universitätsklinikum Regensburg

Regensburg, Germany

Kintampo Health Research Centre (KHRC)

Kintampo, Bono East, Ghana

Ghana Institute of Clinical Genetics, Korle Bu Teaching Hospital (KBTH)

Accra, Ghana

General University Hospital of Patras

Pátrai, Larissa, Greece

Gen Hosp Athens Ippokrateio,B' Uni Clinic Internal Medicine

Athens, Greece

General Hospital Of Larissa Koutlibaneio And Triantafylleio - Thalassemia and SCD Unit

Larissa, Greece

'Ippokrateio' General Hospital of Thessaloniki

Thessaloniki, Greece

K.J Somaiya Hospital and Research Centre

Mumbai, Maharashtra, India

Yashoda Hospital

Hyderabad, Telangana, India

Victoria Hospital, Bangalore

Bangalore, India

Srirama Chandra Bhanj Medical College & Hospital (S.C.B Medical College)

Cutack, India

All India Institute of Medical Sciences (AIIMS)

New Delhi, India

Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo

Pavia, PV, Italy

Azienda Ospedaliero Universitaria Policlinico G. Rodolico - San Marco

Catania, Italy

Azienda Ospedaliera Universitaria San Luigi Gonzaga - S.C.D.O. Microcitemie e malattie rare ematologiche

Orbassano, Italy

Azienda Ospedale Universita Padova

Padova, Italy

ARNAS Ospedali Civico Di Cristina Benfratelli - Presidio Ospedaliero "Civio e Benfratelli"

Palermo, Italy

Ospedale Pediatrico Bambino Ges

Roma, Italy

Kombewa Clinical Research Centre

Kisumu, Kenya

KEMRI Kondele Children Hospital, Kisumu

Kisumu, Kenya

KEMRI CRDR Siaya Clinical Research Annex, Country Referral Hospital

Kisumu, Kenya

Gertrude's Children's Hospital

Nairobi, Kenya

Master Centre for Lebanon

Amman, Lebanon

American University of Beirut Medical center

Beirut, Lebanon

Hospital Nini

Tripoli, Lebanon

University of Abuja Teaching Hospital, Gwagwalada, Abuja

Abuja, Nigeria

Barau Dikko Teaching Hospital, Kaduna

Kaduna, Nigeria

Aminu Kano Teaching Hospital (AKTH)

Kano, Nigeria

Lagos University Teaching Hospital, Lagos

Lagos, Nigeria

University of Nigeria Teaching Hospital (UNTH)

Lagos, Nigeria

Sultan Qaboos University Hospital

Muscat, Sultanet of Oman/Muscat/Al Khoud, Oman

King Fahad Specialist Hospital-Dammam

Dammam, Saudi Arabia

Prince Mohammad Bin Naser Hospital

Jizan, Saudi Arabia

King Khaled University Hospital,King Saud Univ. Med. City

Riyadh, Saudi Arabia

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Hospital Germans Trias i Pujol

Badalona, Spain

Hospital Universitario de Cruces

Barakaldo, Spain

Hospital Vall d'Hebron

Barcelona, Spain

Hospital Sant Joan de Déu

Barcelona, Spain

Hospital Gregorio Marañón

Madrid, Spain

Hospital Ramón y Cajal

Madrid, Spain

Hospital Clínico San Carlos

Madrid, Spain

Hospital Universitario La Paz

Madrid, Spain

Hospital Universitario Virgen del Rocío

Seville, Spain

Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi- Hematoloji

Adana, Turkey (Türkiye)

Başkent Üniversitesi Adana Dr. Turgut Noyan Uygulama ve Araştırma Merkezi

Adana, Turkey (Türkiye)

Adana City Training and Research Hospital

Adana, Turkey (Türkiye)

Hacettepe Üniversitesi Hastanesi- Hematoloji

Ankara, Turkey (Türkiye)

Ege Üniversitesi Tip Fakultesi Hastanesi - Nefroloji

Izmir, Turkey (Türkiye)

Mersin Üniversitesi Tip Fakültesi Hastanesi- Çiftlikköy Yerleşkesi- Hematoloji

Mersin, Turkey (Türkiye)

VM Medical Park Mersin Hastanesi- Kardiyoloji

Mersin, Turkey (Türkiye)

Leicester Royal Infirmary - Haemostasis & Thrombosis Unit

Leicester, United Kingdom

University Hospital Lewisham, Lewisham and Greenwich NHS Trust

London, United Kingdom

Guys and St Thomas NHS Foundation Trust / Evelina Childrens Hospital

London, United Kingdom

Kings College Hospital - Haematology

London, United Kingdom

Hammersmith Hospital - London

London, United Kingdom

Churchill Hospital

Oxford, United Kingdom

Royal Hallamshire Hospital

Sheffield, United Kingdom