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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

January 29, 2021

Primary Completion Date

February 20, 2026

Study Completion Date

March 19, 2027

Conditions
Sickle Cell Disease
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

Trial Locations (140)

0

[Legal] Alexandria Clinical Research LLC, Alexandria

Ain Shams University Hospital, Cairo

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

100

Gertrude's Children's Hospital, Nairobi, Nairobi

123

Sultan Qaboos University Hospital, Muscat

200

Kintampo Health Research Centre (KHRC), Kintampo, Ghana, Kintampo

228

University of Abuja Teaching Hospital, Gwagwalada, Abuja, Abuja

961

American University of Beirut Medical center, Beirut

1240

Baskent Universitesi Adana, Adana

1932

Kombewa Clinical Research Centre, Kisumu

3452

Aminu Kano Teaching Hospital (AKTH), Kano

6230

Hacettepe Universitesi, Ankara

10032

Columbia University Medical Center_New York, New York

10043

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

Azienda Ospedaliera Universitaria San Luigi Gonzaga, Orbassano

10461

Jacobi Medical Center, The Bronx

10467

Children's Hospital at Montefiore, The Bronx

Montefiore Medical Center, The Bronx

11042

Long Island Jewish Medical Center, New Hyde Park

11203

Kings County Hospital, Brooklyn

NYC Health+Hospitals, Brooklyn

11956

Al Kasr AL Aini Hospital, Cairo

13353

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

19104

The Children's Hospital of Philadelphia (CHOP), Philadelphia

19107

Thomas Jefferson University Hospital, Philadelphia

20010

Children's National Health Center, Washington D.C.

Children's National Health Hospital, Washington

21131

[Legal] Alexandria Clinical Research LLC, Alexandria

23284

Virginia Commonwealth University, Richmond

23298

Virginia Commonwealth University, Richmond

26504

General University Hospital of Patras, Rio

27100

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

Fondazione IRCCS Policlinico San Matteo, Pavia

27157

Wake Forest Baptist Health, Winston-Salem

27514

UNC School of Medicine, Chapel Hill

27705

Duke University - Sickle Cell Center, Durham

27710

Duke University Medical Center, Durham

27834

East Carolina University (ECU) Physicians, Greenville

27858

East Carolina University, Greenville

28046

Hospital Universitario La Paz, Madrid

Universidad Autonoma de Madrid (UAM) - Hospital Universitario La Paz, Madrid

28204

Levine Cancer Institute, Charlotte

29425

Medical University of South Carolina, Charleston

29605

Prisma Health-Upstate, Greenville

30303

Emory University School of Medicine, Atlanta

30315

Sonar Clinical Research, Atlanta

30322

Emory University School of Medicine, Atlanta

30331

Sonar Clinical Research, Atlanta

30342

Children's Healthcare of Atlanta Investigational Medication Pharmacy, Atlanta

30912

Augusta University Center for Blood Disorders., Augusta

Center for Blood Disorders Augusta University, Augusta

32806

Arnold Palmer Children's Hospital, Orlando

33021

Office of Gershwin T. Blyden, MD, Hollywood

33023

Foundation for Sickle Cell Disease Research, Hollywood

33110

Mersin University Medical Faculty Hospital, Hematology, Mersin

33136

University Of Miami, Miami

33200

VM Medical Park Mersin Hospital, Mersin

34295

CHU Montpellier, Hôpital Saint-Eloi, Montpellier

35128

Azienda Ospedale Universita Padova, Padua

35233

Univ of Alabama Birmingham, Birmingham

35249

University of Alabama at Birmingham (UAB), Birmingham

38104

Methodist University Hospital, Memphis

38105

St. Jude Children's Research Hospital (SJCRH), Memphis

40100

KEMRI Kondele Children Hospital, Kisumu, Kisumu

40600

KEMRI Siaya Clinical Research Annex Siaya County Referral Hospital, Siaya, Kisumu

41221

General Hospital Of Larissa Koutlibaneio And Triantafylleio, Larissa

General University Hospital of Larissa, Larissa

44519

Sydnawy University Hospital, Zagazig

44720

Neuro-Behavioral Clinical Research, North Canton

45229

Cincinnati Childrens Hospital Medical Center, Cincinnati

48013

Hospital De Cruces, Barakaldo

48201

Barbara Ann Karmanos Cancer Institute, Detroit

Detroit Medical Center (DMC) - Children's Hospital of Michigan (CHM), Detroit

48903

Hospital Universitario de Cruces, Barakaldo

53226

Blood Center of Wisconsin (BCW), Milwaukee

Versiti Blood Center of Wisconsin, Milwaukee

54642

'Ippokrateio' General Hospital of Thessaloniki, Thessaloniki

"General Hospital of Thessaloniki Hippokration", Thessaloniki

60612

University of Illinois at Chicago, Chicago

63110

Washington University School of Medicine_St. Louis, St Louis

68100

Hôpital Emile Muller, Mulhouse

69120

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

University Hospital of Heidelberg, Heidelberg

69437

Hospices Civils de Lyon-Hopital Edouard Herriot, Lyon

Hôpital Edouard HERRIOT, Lyon

70118

Children's Hosp-New Orleans, New Orleans

Children's Hospital New Orleans, New Orleans

72211

Woodland International Research Group, Little Rock

75019

Ap-Hp-Hopital Robert Debre, Paris

77030

[Legal] Baylor College of Medicine, Houston

Baylor College of Medicine, Houston

The University of Texas Health Science Center at Houston, Houston

UT Health University of Texas, Houston

79106

Universitätsklinikum Freiburg-Zentrum für Kinder- und Jugendmedizin, Freiburg im Breisgau

82943

Prince Mohammad Bin Naser Hospital, Jizan

85016

Phoenix Children's Hsptl, Phoenix

90806

Collaborative Neuroscience Research, LLC., Long Beach

92697

University of California, Irvine, Irvine

92868

University Of California Irvine, Orange

94010

Ap-Hp-Hopital Henri Mondor, Créteil

Hôpital Henri Mondor, Créteil

98405

Mary Bridge Children's Health, Tacoma

102215

Lagos University Teaching Hospital, Lagos, Lagos

University of Nigeria Teaching Hospital, Enugu, Lagos

111111

Cairo University, Cairo

400022

K.J Somaiya Hospital and Research Centre, Mumbai

560002

Victoria Hospital, Bangalore, Bangalore

800212

Barau Dikko Teaching Hospital, Kaduna, Kaduna

06030

University of Connecticut, Farmington

06519

Yale University, New Haven

02118

Boston Medical Center, Boston

68198-2168

University of Nebraska Medical Center, Omaha

11432-1121

Queens Hospital Center, Jamaica

V6E 1M7

Providence Hematolgy, Vancouver

M5G 1X8

The Hospital for Sick Children, Toronto

M5G 2C4

University Health Network - Toronto General Hospital, Toronto

H3T 1C5

Universite de Montreal - Centre Hospitalier Universitaire (CHU) Sainte-Justine, Montreal

V6Z 2A5

Providence Hematology, Vancouver

Unknown

Alexandria Clinical Research Center, Alexandria

Alexandria Faculty of Medicine - Clinical Research Center, Alexandria

CHU Paris - Hôpital Robert Debré, Paris

Univertatsklinikum Frankfurt, Frankfurt

UKE Hamburg, Hamburg

IRCCS Ospedale Pediatrico Bambino Gesu, Rome

Nini Hospital, Tripoli

265 04

General University Hospital of Patras, Pátrai

115 27

Gen Hosp Athens Ippokrateio,B' Uni Clinic Internal Medicine, Athens

Hippocratio General Hospital, Athens

113-6044

Hospital Nini, Tripoli

12372 6864

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

08035

Hospital Universitari Vall d'Hebron de Barcelona, Barcelona

Hospital Vall d'Hebron, Barcelona

SE18 3RA

Guys and St Thomas NHS Foundation Trust / Evelina Childrens Hospital, London

SE5 9RS

Kings College Hospital, London

W2 1NY

Hammersmith Hospital - Imperial College Healthcare NHS Trust, London

Imperial College Healthcare NHS Trust - Hammersmith Hospital, London

OX3 7LE

Churchill Hospital, Oxford

Oxford University Hospitals NHS Trust - Churchill Hospital - Cancer and Haematology Centre, Oxford

S10 2JF

The Royal Hallamshire Hospital, Sheffield Teaching Hospital NHS Foundation Trust, Sheffield

S11 8RN

Royal Hallamshire Hospital, Sheffield

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novo Nordisk A/S

INDUSTRY

lead

Forma Therapeutics, Inc.

INDUSTRY