Phase
Condition
Sickle Cell Disease
Red Blood Cell Disorders
Treatment
Placebo
NDec - oral decitabine-tetrahydrouridine
HU - Hydroxyurea
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age above or equal to 18 years at the time of signing informed consent
Confirmed diagnosis of SCD (including HbSS, HbSC, HbSβ0 thalassaemia and HbSβ+thalassaemia or other Sickle Cell disease variants)
2-10 episodes of documented vaso-occlusive crisis (VOCs) within the last 12 monthsprior to the screening visit
Haemoglobin greater than or equal to 5.0 g/dL and below or equal to 10.5 g/dL atvisit 1
Absolute reticulocyte count above upper limit of the normal (ULN) at visit 1
Body weight 40 to 125 kg (inclusive).
Exclusion
Exclusion Criteria:
Patient is on chronic transfusion therapy as defined by receiving scheduled (pre-planned) series of blood transfusion (simple or exchange) for prophylacticpurposes, or the patient is likely to begin chronic transfusion therapy during thecourse of the trial, or has received RBC or whole blood transfusion for any reasonwithin 28 days of visit 1
Receipt of erythropoietin or other haematopoietic growth factor treatment within 28days of signing ICF, or planned treatment with these agents during the trial
Receipt of voxelotor, crizanlizumab or L-glutamine treatment within 12 weeks ofsigning the informed consent form, or planned treatment with such agents during thetrial
Platelet count greater than 800 x 10^9/L at visit 1
Absolute neutrophil count below or equal to 1.5 x 10^9/L at visit 1
Any condition/concurrent chronic disease involving the stomach or small intestinewhich may affect drug absorption, as per investigator's judgement
Female who is
pregnant, breast-feeding or intends to become pregnant within 6 months afterthe final trial product administration
child-bearing potential and not using highly effective methods of contraceptionand whose male partner is not using effective contraception, at screening anduntil 6 months after the last dose of trial product
Male with female partner of childbearing potential who does not agree to use condomand whose female partner of childbearing potential is not using a highly effectivecontraceptive measure from trial start to:
Six (6) months after the last dose of trial product for patients onNDec/Placebo
Six (6) months after the last dose of trial product for patients outside US andCA randomised to HU
Twelve (12) months after the last dose of trial product for patients randomisedto HU in US and CA
Study Design
Connect with a study center
LHSC - Victoria Hospital
London, Ontario ON N6A 5W9
CanadaSite Not Available
Novo Nordisk Investigational Site
London, Ontario ON N6A 5W9
CanadaActive - Recruiting
Novo Nordisk Investigational Site
Toronto, Ontario M5G 2C4
CanadaActive - Recruiting
Toronto General Hospital, Liver Clinic
Toronto, Ontario M5G2C4
CanadaSite Not Available
McGill University Health Centre
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Novo Nordisk Investigational Site
Montreal, Quebec H4A 3J1
CanadaSite Not Available
Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-3
Grenoble Cedex 9, 38043
FranceSite Not Available
Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-3
La Tronche, 38700
FranceSite Not Available
Novo Nordisk Investigational Site
La Tronche, 38700
FranceActive - Recruiting
Hospices Civils de Lyon-Hopital Edouard Herriot
Lyon Cedex 03, 69437
FranceSite Not Available
Novo Nordisk Investigational Site
Lyon cedex 03, 69437
FranceActive - Recruiting
Aghia Sophia Childrens' Hospital
Goudi, 11527
GreeceSite Not Available
Novo Nordisk Investigational Site
Goudi, 11527
GreeceActive - Recruiting
General Hospital Of Larissa Koutlibaneio And Triantafylleio
Larissa, 41221
GreeceSite Not Available
Novo Nordisk Investigational Site
Larissa, 41221
GreeceSite Not Available
Gen Univ Hospital of Patras, Thalassemia/Hemoglobinopathies
Patra, 26504
GreeceSite Not Available
Novo Nordisk Investigational Site
Patra, GR-26504
GreeceActive - Recruiting
All India Institute of Medical Sciences (AIIMS), Raipur
Raipur, Chhattisgarh 492099
IndiaSite Not Available
Novo Nordisk Investigational Site
Raipur, Chhattisgarh 492099
IndiaSite Not Available
BAPS Pramukh Swami Hospital
Surat, Gujarat 395009
IndiaSite Not Available
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat 395002
IndiaSite Not Available
Novo Nordisk Investigational Site
Surat, Gujarat 395002
IndiaActive - Recruiting
Novo Nordisk Investigational Site
Vadodara, Gujarat 390006
IndiaSite Not Available
SSG Hospital, Baroda
Vadodara, Gujarat 390006
IndiaSite Not Available
Novo Nordisk Investigational Site
Bangalore, Karnataka 560002
IndiaSite Not Available
Victoria Hospital (Bangalore Medical College and Research Institute)
Bangalore, Karnataka 560002
IndiaSite Not Available
J.S.S.Hospital
Mysore, Karnataka 570004
IndiaSite Not Available
Government Medical College, Kozhikode
Kozhikode, Kerala 673008
IndiaSite Not Available
Novo Nordisk Investigational Site
Kozhikode, Kerala 673008
IndiaSite Not Available
K.J Somaiya Hospital and Research Centre
Mumbai, Maharashtra 400022
IndiaSite Not Available
Government Medical College and Hospital
Nagpur, Maharashtra 440003
IndiaSite Not Available
Government Medical College and Super Speciality Hospital, Nagpur
Nagpur, Maharashtra 440003
IndiaSite Not Available
IMS and SUM Hospital
Bhubaneswar, Orissa 751003
IndiaSite Not Available
Novo Nordisk Investigational Site
Bhubaneswar, Orissa 751003
IndiaActive - Recruiting
S.C.B. Medical College
Cuttack, Orissa 753007
IndiaSite Not Available
Christian Medical College Hospital, Vellore
Ranipet, Tamil Nadu 632517
IndiaSite Not Available
Novo Nordisk Investigational Site
Ranipet, Tamil Nadu 632517
IndiaSite Not Available
Christian Medical College Hospital, Vellore
Vellore, Tamil Nadu 632004
IndiaSite Not Available
Novo Nordisk Investigational Site
Vellore, Tamil Nadu 632004
IndiaActive - Recruiting
Novo Nordisk Investigational Site
Hyderabad, Telengana 500082
IndiaSite Not Available
Yashoda hospital
Hyderabad, Telengana 500082
IndiaSite Not Available
Novo Nordisk Investigational Site
Lucknow, Uttar Pradesh 226014
IndiaSite Not Available
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh 226014
IndiaSite Not Available
NRS Medical College & Hospital
Kolkata, West Bengal 700014
IndiaSite Not Available
NRS Medical College & Hospital
Kolkatta, West Bengal 70014
IndiaSite Not Available
Novo Nordisk Investigational Site
Kolkatta, West Bengal 70014
IndiaSite Not Available
KIMS - Kingsway Hospital
Nagpur, 440001
IndiaSite Not Available
Novo Nordisk Investigational Site
Nagpur, 440001
IndiaActive - Recruiting
Novo Nordisk Investigational Site
Genova, 16128
ItalySite Not Available
Ospedali Galliera
Genova, 16128
ItalySite Not Available
Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico
Milan, 20122
ItalySite Not Available
Novo Nordisk Investigational Site
Milan, 20122
ItalySite Not Available
Azienda Ospedale Universita Padova
Padova, 35128
ItalySite Not Available
Novo Nordisk Investigational Site
Padova, 35128
ItalyActive - Recruiting
Novo Nordisk Investigational Site
Verona, 37134
ItalyActive - Recruiting
Policlinico GB Rossi
Verona, 37134
ItalySite Not Available
Hospital Nini
Tripoli, 1434
LebanonSite Not Available
Novo Nordisk Investigational Site
Tripoli, 1434
LebanonSite Not Available
Sultan Qaboos University Hospital
Muscat, 123
OmanSite Not Available
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Johannesburg, Gauteng 2193
South AfricaSite Not Available
Novo Nordisk Investigational Site
Parktown, Johannesburg, Gauteng 2193
South AfricaActive - Recruiting
Hospital Universitario La Paz
Madrid, 28046
SpainSite Not Available
Novo Nordisk Investigational Site
Madrid, 28046
SpainActive - Recruiting
Hospital Universitario Regional de Málaga
Málaga, 29010
SpainSite Not Available
Novo Nordisk Investigational Site
Málaga, 29010
SpainActive - Recruiting
Novo Nordisk Investigational Site
Zürich, 8091
SwitzerlandSite Not Available
Acibadem Adana Hastanesi
Adana, 01130
TurkeySite Not Available
Cukurova Universitesi
Adana, 01130
TurkeySite Not Available
Novo Nordisk Investigational Site
Adana, 01130
TurkeyActive - Recruiting
Hacettepe University Hematology
Ankara, 06230
TurkeySite Not Available
Novo Nordisk Investigational Site
Ankara, 06230
TurkeySite Not Available
Mersin University Medical Faculty Hospital, Hematology
Mersin, 33110
TurkeySite Not Available
Novo Nordisk Investigational Site
Mersin, 33110
TurkeyActive - Recruiting
Novo Nordisk Investigational Site
Cardiff, CF14 4XW
United KingdomActive - Recruiting
University Hospital of Wales
Cardiff, CF14 4XW
United KingdomSite Not Available
Central Middlesex Hospital
London, NW10 7NS
United KingdomSite Not Available
Guy's Hosptial
London, SE1 9RT
United KingdomSite Not Available
Kings College Hospital
London, SE5 9RS
United KingdomSite Not Available
Novo Nordisk Investigational Site
London, SE1 9RT
United KingdomSite Not Available
Manchester Royal Infirmary_Manchester_0
Manchester, M13 9WL
United KingdomSite Not Available
Novo Nordisk Investigational Site
Manchester, M13 9WL
United KingdomActive - Recruiting
Novo Nordisk Investigational Site
Mobile, Alabama 36617
United StatesSite Not Available
University Of South Alabama
Mobile, Alabama 36617
United StatesSite Not Available
Novo Nordisk Investigational Site
Oakland, California 94609
United StatesSite Not Available
UCSF Oakland Benioff Children's Hospital
Oakland, California 94609
United StatesSite Not Available
Center for Inherited Blood Dis
Orange, California 92868
United StatesSite Not Available
Novo Nordisk Investigational Site
Orange, California 92868
United StatesActive - Recruiting
Harbor-UCLA Medical Center
Torrance, California 90502-2004
United StatesSite Not Available
Novo Nordisk Investigational Site
Torrance, California 90502-2004
United StatesActive - Recruiting
Clinical and Transl Res Center
Aurora, Colorado 80045
United StatesSite Not Available
Novo Nordisk Investigational Site
Aurora, Colorado 80045
United StatesSite Not Available
Howard University
Washington, District of Columbia 20060
United StatesSite Not Available
Novo Nordisk Investigational Site
Washington, District of Columbia 20060
United StatesSite Not Available
Foundation for Sickle Cell Disease Research
Hollywood, Florida 33023
United StatesSite Not Available
Novo Nordisk Investigational Site
Hollywood, Florida 33023
United StatesActive - Recruiting
Novo Nordisk Investigational Site
Miami, Florida 33136
United StatesSite Not Available
University of Miami Hospital & Clinics
Miami, Florida 33136
United StatesSite Not Available
Novo Nordisk Investigational Site
Chicago, Illinois 60612
United StatesSite Not Available
University Of Illinois at Chicago
Chicago, Illinois 60612
United StatesSite Not Available
Novo Nordisk Investigational Site
Metairie, Louisiana 70002
United StatesSite Not Available
Tulane Sickle Cell Ctr- So LA
Metairie, Louisiana 70002
United StatesSite Not Available
Novo Nordisk Investigational Site
New Orleans, Louisiana 07112-2699
United StatesSite Not Available
Mississippi Center Advanced Medicine
Madison, Mississippi 39110
United StatesSite Not Available
Novo Nordisk Investigational Site
Madison, Mississippi 39110
United StatesActive - Recruiting
Cure 4 the Kids Foundation
Las Vegas, Nevada 89135
United StatesSite Not Available
Novo Nordisk Investigational Site
Las Vegas, Nevada 89135
United StatesSite Not Available
Jacobi Medical Center
Bronx, New York 10461
United StatesSite Not Available
Novo Nordisk Investigational Site
Bronx, New York 10461
United StatesSite Not Available
Mount Sinai School of Medicine
New York, New York 10029
United StatesSite Not Available
Novo Nordisk Investigational Site
New York, New York 10029
United StatesSite Not Available
East Carolina University_Greenville_0
Greenville, North Carolina 27834
United StatesSite Not Available
Novo Nordisk Investigational Site
Greenville, North Carolina 27834
United StatesSite Not Available
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
Univ Oklahoma HSC_Okla City
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
University of Oklahoma Health Sciences Center_Oklahoma City
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania 19134
United StatesActive - Recruiting
St Christopher Hosp for Child
Philadelphia, Pennsylvania 19134
United StatesSite Not Available
Medical Univ of SC Charleston
Charleston, South Carolina 29425
United StatesSite Not Available
Novo Nordisk Investigational Site
Charleston, South Carolina 29425
United StatesActive - Recruiting
Novo Nordisk Investigational Site
Houston, Texas 77030
United StatesActive - Recruiting
Univ Texas HSC-Houston
Houston, Texas 77030
United StatesSite Not Available
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