Phase
Condition
Thalassemia
Treatment
Etavopivat B
Etavopivat A
Clinical Study ID
All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Participant must have ongoing participation in an etavopivat parent study fortreatment of sickle cell disease (SCD) or thalassaemia and have completed at least atreatment period of the parent study.
Participant must have derived clinical benefit from treatment with etavopivat, asdetermined by the investigator.
Any participant with dose reduction or temporary discontinuation will need to berechallenged before transferring.
Participants on hydroxyurea (HU), crizanlizumab or l-glutamine oral powder (Endari®)treatment at the time of consent may be eligible if they:
Have been on a stable dose during participation in the parent study (i.e., nochanges to the dose except for changes to weight or age reasons).
Have been compliant with the treatment regimen at the discretion of the investigatorduring participation of the parent study.
Exclusion
Exclusion Criteria:
Any disorder, except for conditions associated with SCD or thalassaemia, which inthe investigator's opinion might jeopardise participant's safety or compliance withthe protocol.
Participant withdrew or had permanent treatment discontinuation from an etavopivatclinical study.
Participants on permanent dose reduction or temporary treatment discontinuation.
Use of any of the following within the timeframes prior to the transfer visit asstated:
Use of voxelotor within participation of the parent study or anticipated need forthis agent during this study.
Use of an experimental selectin antagonist (e.g., monoclonal antibody or smallmolecule) within the parent study or anticipated need for such agents during thisstudy.
Use of erythropoietin or other haematopoietic growth factor treatment within theparent study or anticipated need for such agents during this study.
Receiving or use of concomitant medications that are strong inducers of cytochromeP450 (CYP) 3A4 within 2 weeks of the transfer visit or anticipated need for suchagents during the study.
Current participation in a study that is not a designated parent study, or plannedparticipation in any other clinical trial, for the duration of FLORAL.
Study Design
Connect with a study center
Providence Hematolgy
Vancouver, British Columbia V6E 1M7
CanadaSite Not Available
The Hospital for Sick Children
Toronto, Ontario M5G 1X8
CanadaSite Not Available
University Health Network - Toronto General Hospital
Toronto, Ontario M5G 2C4
CanadaSite Not Available
CHU Ste-Justine
Montreal, Quebec H3T 1C5
CanadaSite Not Available
Alexandria University Hospital
Alexandria, Egypt, 21131
EgyptSite Not Available
Zagazig University Hospital
Alsharkia, Egypt, 44519
EgyptSite Not Available
Faculty of Medicine Ain Shams Medical Research Institute (MASRI)
Cairo, 0
EgyptSite Not Available
Abu El-Reesh El-Mounira Children University Hospital
Cairo, Egypt, 4241317
EgyptSite Not Available
Cairo University
Cairo, Egypt, 11956
EgyptSite Not Available
Ap-Hp-Hopital Henri Mondor
Créteil, 94000
FranceSite Not Available
Hospices Civils de Lyon-Hopital Edouard Herriot
Lyon Cedex 03, 69437
FranceSite Not Available
Ap-Hp-Hopital Robert Debre
Paris, 75019
FranceSite Not Available
Charité - Campus Virchow-Klinikum - Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie
Berlin, 13353
GermanySite Not Available
Charité Campus Virchow Klinikum - Klinik für Pädiatrie mit Schwerpunkt Onkologie und Hämatologie
Berlin, 13353
GermanySite Not Available
Universitätsklinikum Freiburg, Kinder- und Jugendklinik
Freiburg, 79106
GermanySite Not Available
Universitätsklinikum Freiburg, Zentrum für Kinder- und Jugendmedizin
Freiburg, 79106
GermanySite Not Available
Ghana Institute of Clinical Genetics, Korle Bu Teaching Hospital (KBTH)
AccrA, 0
GhanaSite Not Available
Kintampo Health Research Centre (KHRC), Kintampo, Ghana
Kintampo, 200
GhanaSite Not Available
General Hospital Of Larissa Koutlibaneio And Triantafylleio
Larissa, Thessaly 41221
GreeceSite Not Available
Hippokration Hospital
Athens, 11527
GreeceActive - Recruiting
General University Hospital of Patras
Patra, 26504
GreeceActive - Recruiting
'Ippokrateio' General Hospital of Thessaloniki
Thessaloniki, 54642
GreeceSite Not Available
All India Institute of Medical Sciences (AIIMS), Raipur
Raipur, Chhattisgarh 492099
IndiaSite Not Available
Nirmal Hospital Pvt. Ltd.
Gujarat, 395002
IndiaSite Not Available
Suretech Hospital and Research Centre Ltd.
Maharashtra, 440012
IndiaSite Not Available
All India Institute of Medical Sciences_Delhi
New Delhi, 110029
IndiaSite Not Available
Azienda Ospedaliera Universitaria San Luigi Gonzaga
Orbassano, Torino 10043
ItalyActive - Recruiting
Azienda Ospedale Universita Padova
Padova, 35128
ItalyActive - Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100
ItalySite Not Available
KEMRI-Walter-Reed Kericho
Kericho, 20200
KenyaSite Not Available
Ahero Clinical Trials Unit, Kisumu, Kenya
Kisumu, 40100
KenyaSite Not Available
KEMRI Kondele Children Hospital, Kisumu
Kisumu, 40100
KenyaSite Not Available
Kombewa Clinical Research Centre
Kisumu, 1932
KenyaSite Not Available
Gertrude's Children's Hospital, Nairobi
Nairobi, 00000
KenyaSite Not Available
KEMRI Siaya Clinical Research Annex Siaya County Referral Hospital, Siaya
Siaya, 0000
KenyaSite Not Available
American University of Beirut Medical Centre
Hamra,
LebanonSite Not Available
Chronic Care Center
Hazmieh, 21211
LebanonSite Not Available
Hospital Nini
Tripoli, 1434
LebanonSite Not Available
University College Hospital Paediatric Haematology and Oncology Unit, Ibadan
Ibadan, Oyo State 0000
NigeriaSite Not Available
University of Abuja Teaching Hospital, Gwagwalada, Abuja
Abuja, 228
NigeriaSite Not Available
University of Nigeria Teaching Hospital, Enugu
Enugu, 00000
NigeriaSite Not Available
Barau Dikko Teaching Hospital, Kaduna
Kaduna, 800212
NigeriaSite Not Available
Aminu Kano Teaching Hospital (AKTH)
Kano, 3452
NigeriaSite Not Available
Lagos University Teaching Hospital, Lagos
Lagos, 102215
NigeriaSite Not Available
Sultan Qaboos University Hospital
Muscat, 123
OmanSite Not Available
Prince Mohammad Bin Naser Hospital
Jizan, 82943
Saudi ArabiaSite Not Available
King Khalid University Hospital
Riyadh, 12372
Saudi ArabiaSite Not Available
Hospital Universitario de Cruces
Baracaldo, 48903
SpainSite Not Available
Hospital Vall d'Hebron
Barcelona, 08035
SpainActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainActive - Recruiting
Baskent Universitesi Adana
Adana, 01250
TurkeySite Not Available
Hacettepe University Hematology
Ankara, 06230
TurkeySite Not Available
Mersin University Medical Faculty Hospital, Hematology
Mersin, 33110
TurkeySite Not Available
Mersin University Medical Faculty Pediatric Hematology
Mersin, 33110
TurkeySite Not Available
Imperial College London
London, W12 0NN
United KingdomSite Not Available
Kings College Hospital
London, SE5 9RS
United KingdomSite Not Available
Manchester Royal Infirmary_Manchester_0
Manchester, M13 9WL
United KingdomSite Not Available
Royal Hallamshire Hospital
Sheffield, S10 2JF
United KingdomActive - Recruiting
Univ of Alabama Birmingham
Birmingham, Alabama 35233
United StatesActive - Recruiting
Phoenix Children's Hsptl
Phoenix, Arizona 85016
United StatesSite Not Available
University Of California Irvine
Irvine, California 92697
United StatesSite Not Available
Children's Hospital Los Angeles - Endocrinology
Los Angeles, California 90027
United StatesActive - Recruiting
UCSF Oakland Benioff ChildHosp
Oakland, California 94609
United StatesSite Not Available
Children's Hosp Of Orange
Orange, California 92868
United StatesSite Not Available
University Of California Irvine
Orange, California 92868
United StatesActive - Recruiting
University of Connecticut
Farmington, Connecticut 06030
United StatesSite Not Available
Children's National Medical Center
Washington, District of Columbia 20010
United StatesSite Not Available
Foundation for Sickle Cell Disease Research
Hollywood, Florida 33021
United StatesSite Not Available
Univ Miami-Miller School Med
Miami, Florida 33136
United StatesSite Not Available
Univ of Miami/SCCC
Miami, Florida 33136
United StatesSite Not Available
Children's Healthcare Atlanta
Atlanta, Georgia 30329
United StatesSite Not Available
Emory University School of Medicine
Atlanta, Georgia 30303
United StatesSite Not Available
Center for Blood Disorders Augusta University
Augusta, Georgia 30912
United StatesSite Not Available
Children's Hosp-New Orleans
New Orleans, Louisiana 70118
United StatesSite Not Available
Boston Medical Center
Boston, Massachusetts 02118
United StatesActive - Recruiting
Washington University-St.Louis
Saint Louis, Missouri 63110
United StatesSite Not Available
Jacobi Medical Center
Bronx, New York 10461
United StatesActive - Recruiting
Montefiore Medical Center
Bronx, New York 10467
United StatesSite Not Available
NYC Health+Hospitals
Brooklyn, New York 11203
United StatesActive - Recruiting
Columbia University Medical Center_New York_0
New York, New York 10032
United StatesSite Not Available
Weill Cornell Med Coll-NYPH
New York, New York 10065
United StatesSite Not Available
Duke University_Durham
Durham, North Carolina 27705
United StatesSite Not Available
East Carolina University_Greenville
Greenville, North Carolina 27834
United StatesSite Not Available
Atrium Health-Wake Forest Bapt
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Cincinnati Child's Hsp Med Ctr
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Neuro-Behavioral Clinical Research
North Canton, Ohio 44720
United StatesActive - Recruiting
Medical University Of South Carolina_Charleston
Charleston, South Carolina 29425
United StatesSite Not Available
East Carolina Univ-Greenville
Greenville, South Carolina 27858
United StatesSite Not Available
East Carolina University_Greenville_0
Greenville, South Carolina 27858
United StatesSite Not Available
UTHSC-Memphis
Memphis, Tennessee 38104
United StatesSite Not Available
Texas Children's Hospital_Houston
Houston, Texas 77030
United StatesSite Not Available
UT Health University of Texas
Houston, Texas 77030
United StatesSite Not Available
Virginia Comm Univ Medical Ctr
Richmond, Virginia 23298
United StatesSite Not Available
Mary Bridge Children's Health
Tacoma, Washington 98405
United StatesActive - Recruiting
Versiti, CCBD_Milwaukee
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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