Actively Recruiting

Phase 3
Age: 12Years +
All Genders
NCT06612268

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

Led by Novo Nordisk A/S · Updated on 2026-04-24

408

Participants Needed

172

Research Sites

212 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female.
  • Age 12 years or above at the time of signing the informed consent.
  • Confirmed diagnosis of sickle cell disease with documented genotype.
  • Between 1 and 15 documented vaso-occlusive crises within 12 months prior to screening.
  • Hemoglobin level between 5.0 and 10.0 g/dL at screening.
Not Eligible

You will not qualify if you...

  • More than 15 vaso-occlusive crises in the past 12 months.
  • Use of voxelotor or similar agents within 28 days before starting study treatment.
  • Use of selectin antagonists within 28 days or 5 half-lives before starting study treatment.
  • Receiving regular blood transfusion therapy or 6 or more transfusions in the past 12 months.
  • Received a blood transfusion within 60 days before screening unless hemoglobin A is less than 10%.
  • Use of strong CYP3A4 inducers within 2 weeks before starting study treatment.
  • Use of erythropoietin or other blood growth factors within 28 days before treatment.
  • Prior cellular-based therapy such as stem cell transplant or gene therapy.
  • Significant liver dysfunction with ALT over 4 times the upper limit or direct bilirubin over 3 times the upper limit.
  • Unable or not taking antimalarial prophylaxis if living in malaria areas.
  • Severe kidney dysfunction with eGFR less than or equal to 30 mL/min/1.73 m2 or on dialysis.
  • Walking distance below 100 meters on a standardized 6-minute walk test at screening.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 172 locations

1

Uni of Alabama at Birmingham

Birmingham, Alabama, United States, 35233

Actively Recruiting

2

Univer South Alabama Ped/Onc

Mobile, Alabama, United States, 36604

Actively Recruiting

3

Phoenix Children's Hsptl

Phoenix, Arizona, United States, 85016

Actively Recruiting

4

Arkansas Children's Hospital

Little Rock, Arkansas, United States, 72202

Actively Recruiting

5

Children's Hospital Los Angeles - Endocrinology

Los Angeles, California, United States, 90027

Actively Recruiting

6

UCLA Health

Los Angeles, California, United States, 90095

Actively Recruiting

7

Valley Children's Hospital

Madera, California, United States, 93636

Actively Recruiting

8

University Of California Irvine

Orange, California, United States, 92868

Completed

9

Stanford University_Palo Alto

Palo Alto, California, United States, 94304

Actively Recruiting

10

Harbor-UCLA Medical Center

Torrance, California, United States, 90502

Actively Recruiting

11

Clinical and Transl Res Center

Aurora, Colorado, United States, 80045

Completed

12

Nemours/AI duPont Hosp-Chld

Wilmington, Delaware, United States, 19803

Actively Recruiting

13

Childrens National Medical Ctr

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

14

MedStar Hlth Res Institute

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

15

Memorial Healthcare

Hollywood, Florida, United States, 33021

Actively Recruiting

16

Children's Healthcare Atlanta

Atlanta, Georgia, United States, 30329

Actively Recruiting

17

Childrens Hospital of Chicago

Chicago, Illinois, United States, 60611

Actively Recruiting

18

Univer Of Illinois at Chicago

Chicago, Illinois, United States, 60612

Actively Recruiting

19

Children's Hosp-New Orleans

New Orleans, Louisiana, United States, 70118

Actively Recruiting

20

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

21

Boston Medical Center

Boston, Massachusetts, United States, 02118-2393

Actively Recruiting

22

Henry Ford Hospital_Detroit

Detroit, Michigan, United States, 48202

Completed

23

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

24

Washington University-St.Louis

St Louis, Missouri, United States, 63110

Actively Recruiting

25

Children's Nebraska

Omaha, Nebraska, United States, 68114

Actively Recruiting

26

Cure 4 the Kids Foundation

Las Vegas, Nevada, United States, 89135

Completed

27

Newark Beth Israel MC

Newark, New Jersey, United States, 07112-2027

Not Yet Recruiting

28

NYC Health+Hospitals

Brooklyn, New York, United States, 11203

Actively Recruiting

29

Interfaith Medical Center

Brooklyn, New York, United States, 11238

Actively Recruiting

30

Northwell Health

Mount Kisco, New York, United States, 10549

Completed

31

Cohen Children's Medical Ctr

Queens, New York, United States, 11040

Actively Recruiting

32

Jacobi Medical Center

The Bronx, New York, United States, 10461

Actively Recruiting

33

Montefiore Medical Ctr

The Bronx, New York, United States, 10467

Actively Recruiting

34

Duke Comprehen Sickle Cell

Durham, North Carolina, United States, 27710

Actively Recruiting

35

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

36

East Carolina Univ-Greenville

Greenville, North Carolina, United States, 27834

Actively Recruiting

37

Atrium Health-Wake Forest Bapt

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

38

Univ Hosp Cleveland Med Ctr

Cleveland, Ohio, United States, 44106

Actively Recruiting

39

Ohio State Univ Wexner Med Ctr

Columbus, Ohio, United States, 43203

Actively Recruiting

40

Univ of OK Health Sciences Ctr

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

41

Children's Hosptl Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

42

St Christopher Hosp for Child

Philadelphia, Pennsylvania, United States, 19134

Actively Recruiting

43

University of Tennessee Health Science Center

Memphis, Tennessee, United States, 38104

Actively Recruiting

44

St. Jude Children's Res Hosp

Memphis, Tennessee, United States, 38105

Actively Recruiting

45

UT Health University of Texas

Houston, Texas, United States, 77030

Actively Recruiting

46

Inova Health System

Fairfax, Virginia, United States, 22031

Actively Recruiting

47

Children's Hsptl Of The Kings

Norfolk, Virginia, United States, 23507

Actively Recruiting

48

Virginia Comm Univ Medical Ctr

Richmond, Virginia, United States, 23298

Actively Recruiting

49

Mary Bridge Children's Health

Tacoma, Washington, United States, 98405

Actively Recruiting

50

Mary Bridge Children's Health

Tacoma, Washington, United States, 98405

Not Yet Recruiting

51

Royal Prince Alfred Hospital - Department of Haematology

Camperdown, New South Wales, Australia, 2050

Actively Recruiting

52

Prince of Wales Hospital - Department of Haematology

Randwick, New South Wales, Australia, 2031

Actively Recruiting

53

Monash Medical Centre - Haematology Department

Clayton, Victoria, Australia, 3168

Actively Recruiting

54

Fiona Stanley Hospital - Haemophilia and Haemostasis Centre

Murdoch, Western Australia, Australia, 6150

Actively Recruiting

55

CHU Saint-Pierre - UMC Sint-Pieter

Brussels, Belgium, 1000

Actively Recruiting

56

CHU - UVC Brugmann

Brussels, Belgium, 1020

Not Yet Recruiting

57

HUB - Hôpital Erasme

Brussels, Belgium, 1070

Actively Recruiting

58

UZ Antwerpen - UZA - Haematology

Edegem, Belgium, 2650

Actively Recruiting

59

UZ Antwerpen - UZA - Kinderhemato-Oncologie

Edegem, Belgium, 2650

Actively Recruiting

60

UZ Leuven - Kindergeneeskunde

Leuven, Belgium, 3000

Actively Recruiting

61

MultiHemo - Grupo Oncoclínicas

Recife, Pernambuco, Brazil, 50070-460

Actively Recruiting

62

MultiHemo - Grupo Oncoclínicas

Recife, Pernambuco, Brazil, 52070-460

Not Yet Recruiting

63

Hemocentro UNICAMP

Distrito de Barão Geraldo - Campinas, São Paulo, Brazil, 13083-878

Actively Recruiting

64

HC da FMUSP Hospital das Clínicas São Paulo

São Paulo, São Paulo, Brazil, 05403-010

Actively Recruiting

65

HC da FMUSP Hospital das Clínicas São Paulo

São Paulo, São Paulo, Brazil, 05403-010

Not Yet Recruiting

66

Fundação Hemocentro de Ribeirão Preto

Ribeirão Preto, São, Brazil, 14051-140

Actively Recruiting

67

Hemorio-Fundarj

Rio de Janeiro, Brazil, 20211-030

Actively Recruiting

68

Hospital Samaritano Higienópolis - Instituto de Conhecimento Ensino e Pesquisa (ICEP)

São Paulo, Brazil, 01229-001

Actively Recruiting

69

Foothills Med Ctr-Univ Calgary

Calgary, Alberta, Canada, T2N 2T9

Actively Recruiting

70

Stollery Children's Hospital

Edmonton, Alberta, Canada, T6G 2B7

Not Yet Recruiting

71

University of Alberta_Edmonton

Edmonton, Alberta, Canada, T6G 2B7

Actively Recruiting

72

BC Children's Hospital

Vancouver, British Columbia, Canada, V6H 3V4

Actively Recruiting

73

St Pauls Hospital

Vancouver, British Columbia, Canada, V6Z 2A5

Not Yet Recruiting

74

LHSC - Victoria Hospital

London, Ontario, Canada, N6A5W9

Actively Recruiting

75

Scarborough Health Network Research Institute (SHNRI)

Scarborough Village, Ontario, Canada, M1E 4B9

Not Yet Recruiting

76

UHN-Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

Completed

77

University of Toronto

Toronto, Ontario, Canada, M5G1X8

Not Yet Recruiting

78

CHUM-Hosp de Univ Montreal

Montreal, Quebec, Canada, H2X 0C1

Actively Recruiting

79

Montreal Children's Hospital

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

80

Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia, 50034

Not Yet Recruiting

81

Clinica de la Costa

Barranquilla, Atlántico, Colombia, 80020

Actively Recruiting

82

Sociedad de Oncología y Hematología del Cesar SAS (SOHEC)

Valledupar, Cesar Department, Colombia, 200001

Actively Recruiting

83

Clínica IMAT Oncomedica Auna S.A.S.

Montería, Departamento de Córdoba, Colombia, 230002

Actively Recruiting

84

Centro de investigaciones clínicas, fudación valle del lili

Cali, Valle del Cauca Department, Colombia, 760032

Not Yet Recruiting

85

Sociedad de Oncología y Hematología del Cesar SAS (SOHEC)

Antioquia, Colombia, 4006

Not Yet Recruiting

86

Centro de investigaciones clínicas, fudación valle del lili

Cali, Colombia, 760032

Not Yet Recruiting

87

Clínica IMAT Oncomedica Auna S.A.S.

Montería, Colombia, 230002

Not Yet Recruiting

88

Ap-Hp-Hopital Avicenne

Bobigny, France, 93000

Not Yet Recruiting

89

Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin

Bordeaux, France, 33000

Actively Recruiting

90

Ap-Hp-Hopital Henri Mondor

Créteil, France, 94000

Actively Recruiting

91

Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon

Grenoble, France, 38043

Actively Recruiting

92

Hospices Civils de Lyon-Hopital Edouard Herriot

Lyon, France, 69437

Actively Recruiting

93

AP-HP-HOPITAL NECKER_Service d'hématologie

Paris, France, 75015

Not Yet Recruiting

94

Ap-Hp-Hopital Robert Debre

Paris, France, 75019

Actively Recruiting

95

Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle

Rouen, France, 76031

Not Yet Recruiting

96

Kintampo Health Research Centre (KHRC)

Kintampo, Bono East, Ghana, 27WF+98M

Not Yet Recruiting

97

Navrongo Health Research Centre

Navrongo, Upper East Region, Ghana, UB-03821

Not Yet Recruiting

98

Agogo Presbyterian Hospital, Ghana

Agogo, Ghana, 0000

Completed

99

"Laiko" General Hospital of Athens

Athens, Greece, 115 26

Actively Recruiting

100

Childrens' Hospital of Athens "Agia Sofia"

Athens, Greece, 115 27

Actively Recruiting

101

Hippokration Hospital

Athens, Greece, 11527

Actively Recruiting

102

Hippokration Hospital

Athens, Greece, 11527

Not Yet Recruiting

103

University General Hospital Of Ioannina

Ioannina, Greece, 45500

Actively Recruiting

104

University General Hospital Of Ioannina

Ioannina, Greece, 45500

Not Yet Recruiting

105

"AHEPA" University General Hospital of Thessaloniki

Thessaloniki, Greece, 546 36

Actively Recruiting

106

"AHEPA" University General Hospital of Thessaloniki

Thessaloniki, Greece, 546 36

Not Yet Recruiting

107

Gauhati Medical College and Hospital

Guwahati, Assam, India, 781032

Actively Recruiting

108

All India Institute of Medical Sciences (AIIMS), Raipur

Raipur, Chhattisgarh, India, 492099

Actively Recruiting

109

Zydus Medical College & Hospital

Dohad, Gujarat, India, 389151

Actively Recruiting

110

Nirmal Hospital Pvt. Ltd.

Surat, Gujarat, India, 395002

Actively Recruiting

111

SSG Hospital, Baroda

Vadodara, Gujarat, India, 390001

Actively Recruiting

112

HOCC Haemato Oncology Care Centre

Vadodara, Gujarat, India, 390020

Actively Recruiting

113

JSS Hospital, Mysore

Mysuru, Karnataka, India, 570004

Actively Recruiting

114

Government Medical College, Kozhikode

Kozhikode, Kerala, India, 673008

Actively Recruiting

115

Government Medical College, Kozhikode

Kozhikode, Kerala, India, 673008

Not Yet Recruiting

116

Arihant Multispeciality Hospital

Nagpur, Maharashtra, India, 440026

Actively Recruiting

117

IMS and SUM Hospital

Bhubaneswar, Odisha, India, 751003

Actively Recruiting

118

RNT Medical College

Udaipur, Rajasthan, India, 313001

Not Yet Recruiting

119

NIZAM'S Institute of Medical Sciences

Hyderabad, Telangana, India, 500082

Actively Recruiting

120

Post Graduate Institute of Child Health

Noida, Uttar Pradesh, India, 201303

Actively Recruiting

121

All India Institute of Medical Sciences_New Dehli

New Delhi, India, 110029

Actively Recruiting

122

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

Orbassano, Torino, Italy, 10043

Actively Recruiting

123

Azienda Ospedaliera Universitaria San Luigi Gonzaga

Orbassano, Torino, Italy, 10043

Not Yet Recruiting

124

Azienda Ospedaliera Universitaria Integrata Verona Policlinico GB Rossi - Borgo Roma - Centro Ricerche Cliniche Di Verona S.r.l.

Verona, Veneto, Italy, 37134

Actively Recruiting

125

ASST Civili di Brescia

Brescia, Italy, 25123

Actively Recruiting

126

ARNAS Garibaldi Catania - Presidio Ospedaliero Garibaldi-Centro

Catania, Italy, 95123

Actively Recruiting

127

Azienda Ospedaliero Universitaria Di Modena - UOC Pediatria ad indirizzo Oncoematologico

Modena, Italy, 41100

Not Yet Recruiting

128

Fondazione IRCCS San Gerardo dei Tintori

Monza, Italy, 20900

Actively Recruiting

129

A.O.U. Università Studi della Campania "Luigi Vanvitelli"

Naples, Italy, 80138

Actively Recruiting

130

Azienda Ospedale Universita Padova

Padova, Italy, 35128

Actively Recruiting

131

Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello

Palermo, Italy, 90146

Actively Recruiting

132

Gertrude's Children's Hospital

Nairobi, Nairobi County, Kenya, 00509

Not Yet Recruiting

133

KEMRI CRDR Siaya Clinical Research Annex, Country Referral Hospital

Siaya, Siaya County, Kenya, 40600

Not Yet Recruiting

134

International Cancer Institute (ICI)

Eldoret, Uasin Gishu County, Kenya, 8088-30100

Not Yet Recruiting

135

Ahero Clinical Trials Unit

Kisumu, Kenya, 40101

Not Yet Recruiting

136

American University of Beirut Medical Centre

Hamra, Lebanon, 11-0236

Actively Recruiting

137

Hospital Nini

Tripoli, Lebanon, 1434

Actively Recruiting

138

AmsterdamUMC VUMC - Hematologie

Amsterdam, Netherlands, 1081 HV

Actively Recruiting

139

Erasmus MC

Rotterdam, Netherlands, 3015 GD

Actively Recruiting

140

HagaZiekenhuis

The Hague, Netherlands, 2545AA

Actively Recruiting

141

UMC Utrecht, Van Creveldkliniek

Utrecht, Netherlands, 3584 CX

Actively Recruiting

142

University of Nigeria Teaching Hospital (UNTH)

Ituku-Ozalla, Enugu State, Nigeria, 400001

Not Yet Recruiting

143

Centre of Excellence for Sickle Cell Disease Research and Training, University of Abuja (CESRTA)

Abuja, Federal Capital Territory (fct), Nigeria, 90410

Not Yet Recruiting

144

University College Hospital Paediatric Haematology and Oncology Unit, Ibadan

Ibadan, Oyo State, Nigeria, 0000

Not Yet Recruiting

145

Lagos University Teaching Hospital, Lagos

Lagos, Nigeria, 102215

Not Yet Recruiting

146

Sultan Qaboos University Hospital

Muscat, Sultanet of Oman/Muscat/Al Khoud, Oman, 123

Actively Recruiting

147

The Royal Hospital

Muscat, Oman, 111

Completed

148

King Abdulaziz Hospital-Al Ahsa-National Guard

Al Ahsa, Saudi Arabia, 36428

Actively Recruiting

149

National Guard Hospital Dammam

Dhahran, Saudi Arabia, 34232

Actively Recruiting

150

King Faisal Specialist Hospital & Research Centre, Riyadh

Riyadh, Saudi Arabia, 12713

Actively Recruiting

151

Hospital Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

152

Hospital Vall d'Hebron

Barcelona, Spain, 08035

Not Yet Recruiting

153

Hospital Gregorio Marañón

Madrid, Spain, 28009

Actively Recruiting

154

Hospital Universitario La Paz

Madrid, Spain, 28046

Actively Recruiting

155

Hospital Universitario Virgen del Rocío

Seville, Spain, 41013

Actively Recruiting

156

Acıbadem Adana Hastanesi-Hematoloji

Adana, Turkey (Türkiye), 01130

Actively Recruiting

157

Başkent Üniversitesi Adana-Hematoloji

Adana, Turkey (Türkiye), 01250

Actively Recruiting

158

Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi- Hematoloji

Adana, Turkey (Türkiye), 01250

Actively Recruiting

159

Hacettepe University Hematology

Ankara, Turkey (Türkiye), 06230

Actively Recruiting

160

Hacettepe Üniversitesi Hastanesi- Hematoloji

Ankara, Turkey (Türkiye), 06230

Actively Recruiting

161

Mersin University Medical Faculty Pediatric Hematology

Mersin, Turkey (Türkiye), 33110

Not Yet Recruiting

162

Mersin Üniversitesi Tip Fakültesi Hastanesi- Çiftlikköy Yerleşkesi- Hematoloji

Mersin, Turkey (Türkiye), 33110

Actively Recruiting

163

VM Medical Park Mersin Hastanesi- Kardiyoloji

Mersin, Turkey (Türkiye), 33200

Actively Recruiting

164

Makerere University College of Health Sciences (MakCHS)

Kampala, Central Region, Uganda, 00000

Not Yet Recruiting

165

Joint Clinical Research Centre (JCRC)

Kampala, Central Region (Wakiso District), Uganda, 00000

Not Yet Recruiting

166

Jinja Regional Referral Hospital

Jinja, Eastern Region, Uganda, 0000

Not Yet Recruiting

167

Addenbrooke's Hospital - Haemophilia and Thrombophilia

Cambridge, United Kingdom, CB2 0QQ

Actively Recruiting

168

Whittington Hospital

London, United Kingdom, N19 5NF

Actively Recruiting

169

Guy's Hospital - Haematology

London, United Kingdom, SE1 9RT

Not Yet Recruiting

170

King's College Hospital - Paediatric Research

London, United Kingdom, SE5 9RS

Actively Recruiting

171

Kings College Hospital - Haematology

London, United Kingdom, SE5 9RS

Actively Recruiting

172

Imperial College London

London, United Kingdom, W12 0NN

Actively Recruiting

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Research Team

N

Novo Nordisk

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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