Actively Recruiting

Phase 3
Age: 2Years +
All Genders
NCT06609226

A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia

Led by Novo Nordisk A/S · Updated on 2026-03-24

480

Participants Needed

103

Research Sites

311 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Etavopivat is a new medicine under development for treating blood disorders like sickle cell disease and thalassaemia. Sickle cell disease and thalassaemia are inherited blood disorders that affect haemoglobin. Haemoglobin is the protein that carries oxygen through the body. This study is looking into how safe treatment with etavopivat is and how well it works over a long period of time. The study will last for up to 264 weeks, but it will end earlier if etavopivat is approved in the participant's country.

CONDITIONS

Official Title

A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia

Who Can Participate

Age: 2Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant must be currently participating in an etavopivat parent study for sickle cell disease or thalassemia and have completed at least one treatment period.
  • Participant must have shown clinical benefit from etavopivat treatment as judged by the investigator.
  • Participants with dose reductions or temporary treatment pauses must have been successfully returned to full etavopivat dose before enrolling.
  • Participants on hydroxyurea, crizanlizumab, or l-glutamine oral powder at consent may join if doses have been stable as assessed by the investigator, including weight or age adjustments.
  • Temporary dose reductions or pauses for medical reasons may be accepted if considered stable by the investigator based on overall health and clinical context.
Not Eligible

You will not qualify if you...

  • Any disorder unrelated to sickle cell disease or thalassemia that the investigator believes may risk participant safety or protocol compliance.
  • Participant withdrew from or permanently stopped treatment in an etavopivat clinical study.
  • Participants with permanent dose reductions longer than 28 days or ongoing temporary treatment pauses.
  • Use of hemoglobin S polymerization inhibitors during the parent study or anticipated need during this study.
  • Use of experimental selectin antagonists during the parent study or anticipated need during this study.
  • Use of erythropoietin or other blood growth factors for more than 4 consecutive weeks during the parent study or anticipated need during this study.
  • Use of strong cytochrome P450 3A4 inducing medications within 2 weeks before transfer or anticipated need during the study.
  • Current participation in any clinical study other than a designated parent etavopivat study or planned participation during this study.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 103 locations

1

Univ of Alabama Birmingham

Birmingham, Alabama, United States, 35233

Active, Not Recruiting

2

Phoenix Children's Hsptl

Phoenix, Arizona, United States, 85016

Actively Recruiting

3

Children's Hospital Los Angeles - Endocrinology

Los Angeles, California, United States, 90027

Active, Not Recruiting

4

Children's Hospital Los Angeles - Endocrinology

Los Angeles, California, United States, 90027

Actively Recruiting

5

UCSF Oakland Benioff ChildHosp

Oakland, California, United States, 94609

Active, Not Recruiting

6

UCSF Oakland Benioff ChildHosp

Oakland, California, United States, 94609

Actively Recruiting

7

Children's Hosp Of Orange

Orange, California, United States, 92868

Completed

8

University Of California Irvine

Orange, California, United States, 92868

Actively Recruiting

9

University of Connecticut

Farmington, Connecticut, United States, 06030

Active, Not Recruiting

10

Children's National Medical Center

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

Completed

11

Foundation for Sickle Cell Disease Research

Hollywood, Florida, United States, 33023

Actively Recruiting

12

Univ of Miami/SCCC

Miami, Florida, United States, 33136

Completed

13

Emory University School of Medicine

Atlanta, Georgia, United States, 30303

Active, Not Recruiting

14

Children's Healthcare Atlanta

Atlanta, Georgia, United States, 30329

Actively Recruiting

15

Center for Blood Disorders Augusta University

Augusta, Georgia, United States, 30912

Actively Recruiting

16

Univer Of Illinois at Chicago

Chicago, Illinois, United States, 60612

Not Yet Recruiting

17

Children's Hosp-New Orleans

New Orleans, Louisiana, United States, 70118

Completed

18

Boston Medical Center

Boston, Massachusetts, United States, 02118

Active, Not Recruiting

19

Washington University-St.Louis

St Louis, Missouri, United States, 63110

Actively Recruiting

20

NYC Health+Hospitals

Brooklyn, New York, United States, 11203

Actively Recruiting

21

Columbia University Medical Center_New York_0

New York, New York, United States, 10032

Actively Recruiting

22

Columbia University Medical Center_New York_0

New York, New York, United States, 10032

Not Yet Recruiting

23

Weill Cornell Med Coll-NYPH

New York, New York, United States, 10065

Actively Recruiting

24

Jacobi Medical Center

The Bronx, New York, United States, 10461

Active, Not Recruiting

25

Montefiore Medical Center

The Bronx, New York, United States, 10467

Not Yet Recruiting

26

Atrium Levine Children's/Atrium Health

Charlotte, North Carolina, United States, 28204

Not Yet Recruiting

27

Duke University_Durham

Durham, North Carolina, United States, 27705

Actively Recruiting

28

East Carolina Univ-Greenville

Greenville, North Carolina, United States, 27834

Active, Not Recruiting

29

East Carolina University_Greenville

Greenville, North Carolina, United States, 27834

Completed

30

Atrium Health-Wake Forest Bapt

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

31

Cincinnati Child's Hsp Med Ctr

Cincinnati, Ohio, United States, 45229

Active, Not Recruiting

32

Neuro-Behavioral Clinical Research

North Canton, Ohio, United States, 44720

Active, Not Recruiting

33

Medical University Of South Carolina_Charleston

Charleston, South Carolina, United States, 29425

Actively Recruiting

34

Methodist University Hospital

Memphis, Tennessee, United States, 38104

Actively Recruiting

35

Texas Children's Hospital_Houston

Houston, Texas, United States, 77030

Actively Recruiting

36

UT Health University of Texas

Houston, Texas, United States, 77030

Actively Recruiting

37

Virginia Comm Univ Medical Ctr

Richmond, Virginia, United States, 23298

Actively Recruiting

38

Mary Bridge Children's Health

Tacoma, Washington, United States, 98405

Active, Not Recruiting

39

Versiti, CCBD_Milwaukee

Milwaukee, Wisconsin, United States, 53226

Not Yet Recruiting

40

St Pauls Hospital

Vancouver, British Columbia, Canada, V6Z1Y6

Active, Not Recruiting

41

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1X8

Active, Not Recruiting

42

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada, M5G 2C4

Active, Not Recruiting

43

CHU Ste-Justine

Montreal, Quebec, Canada, H3T 1C5

Active, Not Recruiting

44

Alexandria University Hospital

Alexandria, Egypt, Egypt, 21131

Not Yet Recruiting

45

Zagazig University Hospital

Alsharkia, Egypt, Egypt, 44519

Not Yet Recruiting

46

Faculty of Medicine Ain Shams Medical Research Institute (MASRI)

Cairo, Egypt, 1181

Not Yet Recruiting

47

Cairo University

Cairo, Egypt, Egypt, 11956

Actively Recruiting

48

Abu El-Reesh El-Mounira Children University Hospital

Cairo, Egypt, Egypt, 4241317

Actively Recruiting

49

Ap-Hp-Hopital Henri Mondor

Créteil, France, 94000

Not Yet Recruiting

50

Hospices Civils de Lyon-Hopital Edouard Herriot

Lyon, France, 69437

Not Yet Recruiting

51

Ap-Hp-Hopital Robert Debre

Paris, France, 75019

Actively Recruiting

52

Ap-Hp-Hopital Robert Debre

Paris, France, 75019

Not Yet Recruiting

53

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

Berlin, Germany, 13353

Not Yet Recruiting

54

Universitätsklinikum Freiburg - Kinder- und Jugendklinik

Freiburg im Breisgau, Germany, 79106

Actively Recruiting

55

Kintampo Health Research Centre (KHRC)

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

Not Yet Recruiting

56

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

Accra, Ghana, 0

Not Yet Recruiting

57

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

Larissa, Thessaly, Greece, 41221

Actively Recruiting

58

Hippokration Hospital

Athens, Greece, 11527

Actively Recruiting

59

General University Hospital of Patras

Pátrai, Greece, 26504

Actively Recruiting

60

'Ippokrateio' General Hospital of Thessaloniki

Thessaloniki, Greece, 54642

Actively Recruiting

61

All India Institute of Medical Sciences (AIIMS), Raipur

Raipur, Chhattisgarh, India, 492099

Not Yet Recruiting

62

K.J Somaiya Hospital and Research Centre

Mumbai, Maharashtra, India, 400022

Not Yet Recruiting

63

Victoria Hospital, Bangalore

Bangalore, India, 560002

Not Yet Recruiting

64

Nirmal Hospital Pvt. Ltd.

Gujarat, India, 395002

Not Yet Recruiting

65

Suretech Hospital and Research Centre Ltd.

Maharashtra, India, 440012

Not Yet Recruiting

66

All India Institute of Medical Sciences_Delhi

New Delhi, India, 110029

Not Yet Recruiting

67

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

Orbassano, Torino, Italy, 10043

Actively Recruiting

68

Azienda Ospedale Universita Padova

Padova, Italy, 35128

Actively Recruiting

69

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy, 27100

Actively Recruiting

70

Gertrude's Children's Hospital

Nairobi, Nairobi County, Kenya, 00509

Not Yet Recruiting

71

KEMRI CRDR Siaya Clinical Research Annex, Country Referral Hospital

Siaya, Siaya County, Kenya, 40600

Not Yet Recruiting

72

KEMRI-Walter-Reed Kericho

Kericho, Kenya, 20200

Not Yet Recruiting

73

Kombewa Clinical Research Centre

Kisumu, Kenya, 1932

Not Yet Recruiting

74

KEMRI Kondele Children Hospital, Kisumu

Kisumu, Kenya, 40100

Actively Recruiting

75

Ahero Clinical Trials Unit

Kisumu, Kenya, 40101

Actively Recruiting

76

American University of Beirut Medical Centre

Hamra, Lebanon, 11-0236

Actively Recruiting

77

Chronic Care Center

Hazmiyeh, Lebanon, 21211

Actively Recruiting

78

Hospital Nini

Tripoli, Lebanon, 1434

Actively Recruiting

79

University of Nigeria Teaching Hospital (UNTH)

Ituku-Ozalla, Enugu State, Nigeria, 400001

Not Yet Recruiting

80

University College Hospital Paediatric Haematology and Oncology Unit, Ibadan

Ibadan, Oyo State, Nigeria, 0000

Not Yet Recruiting

81

University of Abuja Teaching Hospital, Gwagwalada, Abuja

Abuja, Nigeria, 228

Not Yet Recruiting

82

Barau Dikko Teaching Hospital, Kaduna

Kaduna, Nigeria, 800212

Not Yet Recruiting

83

Aminu Kano Teaching Hospital (AKTH)

Kano, Nigeria, 3452

Not Yet Recruiting

84

Lagos University Teaching Hospital, Lagos

Lagos, Nigeria, 102215

Not Yet Recruiting

85

Sultan Qaboos University Hospital

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

Actively Recruiting

86

Prince Mohammad Bin Naser Hospital

Jizan, Saudi Arabia, 82943

Not Yet Recruiting

87

King Khalid University Hospital

Riyadh, Saudi Arabia, 12372

Actively Recruiting

88

Hospital Universitario de Cruces

Barakaldo, Spain, 48903

Active, Not Recruiting

89

Hospital Vall d'Hebron

Barcelona, Spain, 08035

Actively Recruiting

90

Hospital Universitario La Paz

Madrid, Spain, 28046

Actively Recruiting

91

Baskent Universitesi Adana

Adana, Turkey (Türkiye), 01250

Not Yet Recruiting

92

Başkent Üniversitesi Adana-Hematoloji

Adana, Turkey (Türkiye), 01250

Actively Recruiting

93

Hacettepe University Hematology

Ankara, Turkey (Türkiye), 06230

Not Yet Recruiting

94

Hacettepe Üniversitesi Hastanesi- Hematoloji

Ankara, Turkey (Türkiye), 06230

Not Yet Recruiting

95

Mersin University Medical Faculty Pediatric Hematology

Mersin, Turkey (Türkiye), 33110

Not Yet Recruiting

96

Mersin Üniversitesi Tip Fakültesi Hastanesi- Çiftlikköy Yerleşkesi- Hematoloji

Mersin, Turkey (Türkiye), 33110

Actively Recruiting

97

Guy's Hospital - Haematology

London, United Kingdom, SE1 9RT

Actively Recruiting

98

Guy's Hospital

London, United Kingdom, SE1 9RT

Not Yet Recruiting

99

King's College Hospital - Paediatric Research

London, United Kingdom, SE5 9RS

Actively Recruiting

100

Kings College Hospital - Haematology

London, United Kingdom, SE5 9RS

Actively Recruiting

101

Imperial College London

London, United Kingdom, W12 0NN

Actively Recruiting

102

Manchester Royal Infirmary

Manchester, United Kingdom, M13 9WL

Actively Recruiting

103

Royal Hallamshire Hospital

Sheffield, United Kingdom, S10 2JF

Actively Recruiting

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Research Team

N

Novo Nordisk

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

5

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A Research Study Looking at Long-term Treatment With Etavopivat in People With Sickle Cell Disease or Thalassaemia | DecenTrialz