A Global Phase 3, Randomised, Double-blind and Placebo-controlled Study Evaluating the Efficacy and Safety of Etavopivat in Adolescents and Adults With Sickle Cell Disease

Status: Recruiting
Location: See all (165) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• Male or female.

• Age 12 years or above at the time of signing the informed consent.

• Confirmed diagnosis of sickle cell disease: Documentation of sickle cell disease (SCD) genotype (HbSS, HbSβ0-thalassemia or other sickle cell syndrome variants) based on prior history of laboratory testing or screening test results from central laboratory. Molecular genotyping is not required. SCD genotype may be determined from the results of haemoglobin (Hb) electrophoresis, high-performance liquid chromatography (HPLC) or similar testing. Note that Hb electrophoresis is performed by the central laboratory at screening.

• Have 1-15 episodes of documented vaso occlusive crises (VOC) within the 12 months prior to screening. Documentation must exist in the participant's medical record prior to randomisation. Events based solely on participant recall without supporting documentation should not be counted towards eligibility.

• Hb greater than or equal to (≥) 5.0 and less than or equal to (≤) 10.0 g/dL (greater than or equal to (≥) 50 and less than or equal to (≤) 100 g/L) at screening.

Locations
United States
Alabama
Uni of Alabama at Birmingham
RECRUITING
Birmingham
Univer South Alabama Ped/Onc
RECRUITING
Mobile
Arkansas
Arkansas Children's Hospital
RECRUITING
Little Rock
Arizona
Phoenix Children's Hsptl
RECRUITING
Phoenix
California
Children's Hospital Los Angeles - Endocrinology
RECRUITING
Los Angeles
UCLA Health
RECRUITING
Los Angeles
Valley Children's Hospital
RECRUITING
Madera
University Of California Irvine
WITHDRAWN
Orange
Stanford University_Palo Alto
RECRUITING
Palo Alto
Harbor-UCLA Medical Center
RECRUITING
Torrance
Colorado
Clinical and Transl Res Center
WITHDRAWN
Aurora
Washington, D.c.
Childrens National Medical Ctr
NOT_YET_RECRUITING
Washington D.c.
MedStar Hlth Res Institute
RECRUITING
Washington D.c.
Delaware
Nemours/AI duPont Hosp-Chld
RECRUITING
Wilmington
Florida
Memorial Healthcare
RECRUITING
Hollywood
Georgia
Children's Healthcare Atlanta
RECRUITING
Atlanta
Illinois
Childrens Hospital of Chicago
RECRUITING
Chicago
Univer Of Illinois at Chicago
NOT_YET_RECRUITING
Chicago
Louisiana
Children's Hosp-New Orleans
RECRUITING
New Orleans
Massachusetts
Boston Children's Hospital
NOT_YET_RECRUITING
Boston
Boston Medical Center
RECRUITING
Boston
Michigan
Henry Ford Hospital_Detroit
WITHDRAWN
Detroit
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Missouri
Washington University-St.Louis
RECRUITING
St Louis
North Carolina
Duke Comprehen Sickle Cell
RECRUITING
Durham
Duke University Medical Center
RECRUITING
Durham
East Carolina Univ-Greenville
RECRUITING
Greenville
Atrium Health-Wake Forest Bapt
RECRUITING
Winston-salem
Nebraska
Children's Nebraska
RECRUITING
Omaha
New Jersey
Newark Beth Israel Medical Center
NOT_YET_RECRUITING
Newark
Nevada
Cure 4 the Kids Foundation
WITHDRAWN
Las Vegas
New York
Interfaith Medical Center
RECRUITING
Brooklyn
NYC Health+Hospitals
RECRUITING
Brooklyn
Northwell Health
NOT_YET_RECRUITING
Mount Kisco
Cohen Children's Medical Ctr
RECRUITING
Queens
Jacobi Medical Center
RECRUITING
The Bronx
Montefiore Medical Ctr
RECRUITING
The Bronx
Ohio
Univ Hosp Cleveland Med Ctr
RECRUITING
Cleveland
Ohio State Univ Wexner Med Ctr
RECRUITING
Columbus
Oklahoma
Univ of OK Health Sciences Ctr
RECRUITING
Oklahoma City
Pennsylvania
Children's Hosptl Philadelphia
RECRUITING
Philadelphia
St Christopher Hosp for Child
RECRUITING
Philadelphia
Tennessee
Methodist University Hospital
NOT_YET_RECRUITING
Memphis
St. Jude Children's Res Hosp
NOT_YET_RECRUITING
Memphis
Texas
UT Health University of Texas
RECRUITING
Houston
Virginia
Inova Health System
RECRUITING
Fairfax
Children's Hsptl Of The Kings
RECRUITING
Norfolk
Virginia Comm Univ Medical Ctr
RECRUITING
Richmond
Washington
Mary Bridge Children's Health
NOT_YET_RECRUITING
Tacoma
Mary Bridge Children's Health
RECRUITING
Tacoma
Other Locations
Australia
Royal Prince Alfred Hospital
RECRUITING
Camperdown
Monash Health
RECRUITING
Clayton
Fiona Stanley Hospital - Haemophilia and Haemostasis Centre
RECRUITING
Murdoch
Prince of Wales Hospital - Department of Haematology
RECRUITING
Randwick
Belgium
CHU - UVC Brugmann
NOT_YET_RECRUITING
Brussels
CHU Saint-Pierre - UMC Sint-Pieter
NOT_YET_RECRUITING
Brussels
HUB - Hôpital Erasme
NOT_YET_RECRUITING
Brussels
UZ Antwerpen - UZA - Haematology
NOT_YET_RECRUITING
Edegem
UZ Antwerpen - UZA - Kinderhemato-Oncologie
NOT_YET_RECRUITING
Edegem
UZ Leuven - Kindergeneeskunde
NOT_YET_RECRUITING
Leuven
Brazil
Hemocentro UNICAMP
RECRUITING
Distrito De Barão Geraldo - Campinas
MultiHemo - Grupo Oncoclínicas
NOT_YET_RECRUITING
Recife
MultiHemo - Grupo Oncoclínicas
NOT_YET_RECRUITING
Recife
Fundação Hemocentro de Ribeirão Preto
RECRUITING
Ribeirão Preto
Hemorio-Fundarj
RECRUITING
Rio De Janeiro
HC da FMUSP Hospital das Clínicas São Paulo
NOT_YET_RECRUITING
São Paulo
HC da FMUSP Hospital das Clínicas São Paulo
RECRUITING
São Paulo
Hospital Samaritano Higienópolis - Instituto de Conhecimento Ensino e Pesquisa (ICEP)
RECRUITING
São Paulo
Canada
Foothills Med Ctr-Univ Calgary
RECRUITING
Calgary
Stollery Children's Hospital
NOT_YET_RECRUITING
Edmonton
University of Alberta_Edmonton
NOT_YET_RECRUITING
Edmonton
LHSC - Victoria Hospital
RECRUITING
London
CHUM-Hosp de Univ Montreal
NOT_YET_RECRUITING
Montreal
Montreal Children's Hospital
NOT_YET_RECRUITING
Montreal
UHN-Toronto General Hospital
WITHDRAWN
Toronto
University of Toronto
NOT_YET_RECRUITING
Toronto
BC Children's Hospital
NOT_YET_RECRUITING
Vancouver
Colombia
Sociedad de Oncología y Hematología del Cesar SAS (SOHEC)
NOT_YET_RECRUITING
Antioquia
Clinica de la Costa
NOT_YET_RECRUITING
Barranquilla
Hospital Pablo Tobon Uribe
NOT_YET_RECRUITING
Medellín
Clínica IMAT Oncomedica Auna S.A.S.
NOT_YET_RECRUITING
Montería
Clínica IMAT Oncomedica Auna S.A.S.
NOT_YET_RECRUITING
Montería
Centro de investigaciones clínicas, fudación valle del lili
NOT_YET_RECRUITING
Santiago De Cali
Centro de investigaciones clínicas, fudación valle del lili
NOT_YET_RECRUITING
Santiago De Cali
Sociedad de Oncología y Hematología del Cesar SAS (SOHEC)
NOT_YET_RECRUITING
Valledupar
France
Ap-Hp-Hopital Avicenne
NOT_YET_RECRUITING
Bobigny
Centre Hospitalier Universitaire de Bordeaux-Hopital Pellegrin
NOT_YET_RECRUITING
Bordeaux
Ap-Hp-Hopital Henri Mondor
NOT_YET_RECRUITING
Créteil
Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-1
NOT_YET_RECRUITING
Grenoble
Hospices Civils de Lyon-Hopital Edouard Herriot
NOT_YET_RECRUITING
Lyon
Ap-Hp-Hopital Necker-1
NOT_YET_RECRUITING
Paris
Ap-Hp-Hopital Robert Debre
NOT_YET_RECRUITING
Paris
Centre Hospitalier Universitaire de Rouen-Hopital Charles Nicolle
NOT_YET_RECRUITING
Rouen
Ghana
Agogo Presbyterian Hospital, Ghana
WITHDRAWN
Agogo
Kintampo Health Research Centre (KHRC), Kintampo, Ghana
NOT_YET_RECRUITING
Kintampo
Navrongo Health Research Centre, Ghana
NOT_YET_RECRUITING
Navrongo
Greece
Childrens' Hospital of Athens Agia Sofia
NOT_YET_RECRUITING
Athens
Hippokration Hospital
NOT_YET_RECRUITING
Athens
Laiko General Hospital of Athens
NOT_YET_RECRUITING
Athens
University General Hospital Of Ioannina
NOT_YET_RECRUITING
Ioannina
AHEPA University General Hospital of Thessaloniki
NOT_YET_RECRUITING
Thessaloniki
India
IMS and SUM Hospital
RECRUITING
Bhubaneswar
Zydus Medical College & Hospital
RECRUITING
Dohad
Gauhati Medical College and Hospital
RECRUITING
Guwahati
NIZAM'S Institute of Medical Sciences
NOT_YET_RECRUITING
Hyderabad
Government Medical College, Kozhikode
RECRUITING
Kozhikode
Government Medical College, Kozhikode
NOT_YET_RECRUITING
Kozhikode
JSS Hospital, Mysore
RECRUITING
Mysuru
Arihant Multispeciality Hospital
RECRUITING
Nagpur
All India Institute of Medical Sciences_New Dehli
RECRUITING
New Delhi
Post Graduate Institute of Child Health
RECRUITING
Noida
All India Institute of Medical Sciences (AIIMS), Raipur
RECRUITING
Raipur
Nirmal Hospital Pvt. Ltd.
RECRUITING
Surat
RNT Medical College
NOT_YET_RECRUITING
Udaipur
HOCC Haemato Oncology Care Centre
RECRUITING
Vadodara
SSG Hospital, Baroda
RECRUITING
Vadodara
Italy
ASST Civili di Brescia
NOT_YET_RECRUITING
Brescia
ARNAS Garibaldi Catania - Presidio Ospedaliero Garibaldi-Centro
NOT_YET_RECRUITING
Catania
Azienda Ospedaliero Universitaria Di Modena - UOC Pediatria ad indirizzo Oncoematologico
NOT_YET_RECRUITING
Modena
Fondazione IRCCS San Gerardo dei Tintori
NOT_YET_RECRUITING
Monza
A.O.U. Università Studi della Campania Luigi Vanvitelli
NOT_YET_RECRUITING
Naples
Azienda Ospedaliera Universitaria San Luigi Gonzaga
NOT_YET_RECRUITING
Orbassano
Azienda Ospedaliera Universitaria San Luigi Gonzaga - S.C.D.O. Microcitemie e malattie rare ematologiche
NOT_YET_RECRUITING
Orbassano
Azienda Ospedale Universita Padova
NOT_YET_RECRUITING
Padua
Azienda Ospedaliera Ospedali Riuniti Villa Sofia - Cervello
NOT_YET_RECRUITING
Palermo
Azienda Ospedaliera Universitaria Integrata Verona Policlinico GB Rossi - Borgo Roma
NOT_YET_RECRUITING
Verona
Kenya
Ahero Clinical Trials Unit, Kisumu, Kenya
NOT_YET_RECRUITING
Kisumu
Gertrude's Children's Hospital, Nairobi
NOT_YET_RECRUITING
Nairobi
KEMRI Siaya Clinical Research Annex Siaya County Referral Hospital, Siaya
NOT_YET_RECRUITING
Siaya
International Cancer Institute (ICI)
NOT_YET_RECRUITING
Uasin Gishu County
Lebanon
American University of Beirut Medical Centre
NOT_YET_RECRUITING
Hamra
Hospital Nini
NOT_YET_RECRUITING
Tripoli
Netherlands
Amsterdam UMC Lokatie VUMC
NOT_YET_RECRUITING
Amsterdam
Erasmus MC
NOT_YET_RECRUITING
Rotterdam
Haga Ziekenhuis
NOT_YET_RECRUITING
The Hague
UMC Utrecht, Van Creveldkliniek
NOT_YET_RECRUITING
Utrecht
Nigeria
Centre for Sickle Cell Disease Research and Training University of Abuja (CESRTA), Abuja
NOT_YET_RECRUITING
Abuja
University of Nigeria Teaching Hospital, Enugu
NOT_YET_RECRUITING
Enugu
University College Hospital Paediatric Haematology and Oncology Unit, Ibadan
NOT_YET_RECRUITING
Ibadan
Lagos University Teaching Hospital, Lagos
NOT_YET_RECRUITING
Lagos
Oman
Sultan Qaboos University Hospital
RECRUITING
Muscat
The Royal Hospital
WITHDRAWN
Muscat
Saudi Arabia
King Abdulaziz Hospital-Al Ahsa-National Guard
RECRUITING
Al Ahsa
National Guard Hospital Dammam
RECRUITING
Dhahran
King Faisal Specialist Hospital & Research Centre, Riyadh
RECRUITING
Riyadh
Spain
Hospital Vall d'Hebron
NOT_YET_RECRUITING
Barcelona
Hospital Gregorio Marañón
NOT_YET_RECRUITING
Madrid
Hospital Universitario La Paz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Virgen del Rocío
NOT_YET_RECRUITING
Seville
Turkey
Acibadem Adana Hastanesi
RECRUITING
Adana
Baskent Universitesi Adana
RECRUITING
Adana
Cukurova University Medical Faculty
RECRUITING
Adana
Hacettepe University Hematology
RECRUITING
Ankara
Mersin University Medical Faculty Pediatric Hematology
NOT_YET_RECRUITING
Mersin
Mersin University Medical Faculty Pediatric Hematology
RECRUITING
Mersin
VM Medical Park Mersin Hospital
RECRUITING
Mersin
Uganda
Jinja Regional Referral Hospital Children's Ward
NOT_YET_RECRUITING
Jinja
Joint Clinical Research Centre (JCRC)
NOT_YET_RECRUITING
Kampala
Makerere University College of Health Sciences
NOT_YET_RECRUITING
Kampala
United Kingdom
Addenbrooke's Hospital
NOT_YET_RECRUITING
Cambridge
Guy's Hospital
NOT_YET_RECRUITING
London
Imperial College London
RECRUITING
London
King's College Hospital - Paediatric Research
NOT_YET_RECRUITING
London
Kings College Hospital
RECRUITING
London
Whittington Hospital
RECRUITING
London
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date: 2025-02-17
Estimated Completion Date: 2029-04-27
Participants
Target number of participants: 408
Treatments
Experimental: Etavopivat
Participants will be randomised to receive oral dose of Etavopivat.
Placebo_comparator: Placebo
Participants will be randomised to receive oral dose of placebo.
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov