Actively Recruiting
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
Eligibility Criteria
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.
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
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
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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