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A Study of Etavopivat in Adults and Adolescents With Sickle Cell Disease (HIBISCUS)
Sponsor: Forma Therapeutics, Inc.
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
Conditions
Interventions
Etavopivat Tablets Low dose
200 mg once daily
Etavopivat Tablets High dose
400 mg once daily
Placebo Tablets
Placebo once daily
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