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Research Study Investigating How Well NDec Works in People With Sickle Cell Disease
Sponsor: Novo Nordisk A/S
Summary
This study examines how well a new, potential medicine called NDec works and is tolerated in people with sickle cell disease. NDec is a combination of two medicines (decitabine-tetrahydrouridine). Both medicines are new for the treatment of sickle cell disease. Participants who are not taking Hydroxyurea (HU) will get NDec, NDec and placebo, or placebo. Participants who are on HU treatment before joining the study will get NDec, NDec and placebo, or continue on HU. Which treatment participants get is decided by chance. Participants getting NDec and/or Placebo will get capsules to take twice weekly. The study will last for about a year.
Official title: A Multicentre Trial Evaluating the Efficacy and Safety of Oral Decitabine Tetrahydrouridine (NDec) in Patients With Sickle Cell Disease
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2022-07-07
Completion Date
2025-07-24
Last Updated
2026-07-22
Healthy Volunteers
No
Conditions
Interventions
NDec - oral decitabine-tetrahydrouridine
Participants will get capsules (oral administration) to take once or twice weekly. The number of capsules will be based on their body weight
HU - Hydroxyurea
Participants will get capsules daily (oral administration) according to local labelling
Placebo
Participants will get capsules (oral administration) to take once or twice weekly. The number of capsules will be based on their body weight
Locations (118)
University Of South Alabama
Mobile, Alabama, United States
Keck Medical Center of USC - Outpatient Clinic
Los Angeles, California, United States
UCSF Oakland Benioff ChildHosp
Oakland, California, United States
Center for Inherited Blood Dis
Orange, California, United States
Harbor-UCLA Medical Center
Torrance, California, United States
Clinical and Transl Res Center
Aurora, Colorado, United States
Carole&Ray Neag Comp S.C. Ctr
Farmington, Connecticut, United States
Tova Community Health Inc
Wilmington, Delaware, United States
Howard University Hospital Department Med
Washington D.C., District of Columbia, United States
Howard University
Washington D.C., District of Columbia, United States
Foundation for Sickle Cell Disease Research
Hollywood, Florida, United States
University of Florida, College of Medicine Jacksonville
Jacksonville, Florida, United States
University of Miami Hospital & Clinics
Miami, Florida, United States
Emory University School Of Med
Atlanta, Georgia, United States
Aflac Cancer/Blood Dis CCH
Atlanta, Georgia, United States
Emory University School Of Med
Atlanta, Georgia, United States
Augusta University
Augusta, Georgia, United States
Rush University Med. Cntr
Chicago, Illinois, United States
Univer Of Illinois at Chicago
Chicago, Illinois, United States
Tulane Sickle Cell Ctr- So LA
Metairie, Louisiana, United States
Mass General Cancer Center
Boston, Massachusetts, United States
Wayne State University/University Health Center
Detroit, Michigan, United States
Children's Hospitals And Clinics Of Minnesota
Minneapolis, Minnesota, United States
University of Minnesota_Minneapolis_0
Minneapolis, Minnesota, United States
Mississippi Center Advanced Medicine
Madison, Mississippi, United States
Univ of NE Med Center_Omaha
Omaha, Nebraska, United States
Cure 4 the Kids Foundation
Las Vegas, Nevada, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Interfaith Medical Center
Brooklyn, New York, United States
Queens Hospital Center
Jamaica, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carlolina-Chapel Hill
Chapel Hill, North Carolina, United States
Atrium Levine Children's/Atrium Health
Charlotte, North Carolina, United States
Duke Comprehen Sickle Cell
Durham, North Carolina, United States
East Carolina Univ-Greenville
Greenville, North Carolina, United States
East Carolina Univ-Greenville
Greenville, North Carolina, United States
Dayton Children's Hosptial
Dayton, Ohio, United States
Univ Oklahoma HSC_Okla City
Oklahoma City, Oklahoma, United States
University of Oklahoma Health Sciences Center_Oklahoma City
Oklahoma City, Oklahoma, United States
Penn Comprehensive Hemophilia & Thrombosis Program
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
St Christopher Hosp for Child
Philadelphia, Pennsylvania, United States
Hemophilia Center of Western PA
Pittsburgh, Pennsylvania, United States
Medical Univ of SC Charleston
Charleston, South Carolina, United States
University Of Tennessee
Memphis, Tennessee, United States
Baylor College of Medicine Texas Childen's Hospital
Houston, Texas, United States
Baylor College of Medicine_Houston
Houston, Texas, United States
Dan L. Duncan Comprehensive Cancer Center
Houston, Texas, United States
Univ Texas HSC-Houston
Houston, Texas, United States
University Of Virginia Hospital
Charlottesville, Virginia, United States
Medical College of Wisconsin & Zablocki VAMC
Milwaukee, Wisconsin, United States
Univ of Alberta Hosp Edmonton
Edmonton, Alberta, Canada
LHSC - Victoria Hospital
London, Ontario, Canada
LHSC - Victoria Hospital
London, Ontario, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Toronto General Hospital, Liver Clinic
Toronto, Ontario, Canada
Toronto General Hospital, Liver Clinic
Toronto, Ontario, Canada
Hospitalier de l'Universite de Montreal (CHUM)-Hôpital Notre
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Ap-Hp-Hopital Henri Mondor
Créteil, France
Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-3
Grenoble, France
Hospices Civils de Lyon-Hopital Edouard Herriot
Lyon, France
Ap-Hp-Hopital Europeen Georges Pompidou
Paris, France
Aghia Sophia Childrens' Hospital
Goudi, Greece
General Hospital Of Larissa Koutlibaneio And Triantafylleio - Thalassemia and SCD Unit
Larissa, Greece
Gen Univ Hospital of Patras, Thalassemia/Hemoglobinopathies
Pátrai, Greece
Gauhati Medical College and Hospital
Guwahati, Assam, India
All India Institute of Medical Sciences (AIIMS), Raipur
Raipur, Chhattisgarh, India
Zydus Medical College & Hospital
Dohad, Gujarat, India
Nirmal Hospital Pvt. Ltd.
Surat, Gujarat, India
BAPS Pramukh Swami Hospital
Surat, Gujarat, India
SSG Hospital, Baroda
Vadodara, Gujarat, India
SSG Hospital, Baroda
Vadodara, Gujarat, India
Victoria Hospital (Bangalore Medical College and Research Institute)
Bangalore, Karnataka, India
J.S.S.Hospital
Mysore, Karnataka, India
Government Medical College, Kozhikode
Kozhikode, Kerala, India
K.J Somaiya Hospital and Research Centre
Mumbai, Maharashtra, India
Government Medical College and Hospital
Nagpur, Maharashtra, India
Government Medical College and Super Speciality Hospital, Nagpur
Nagpur, Maharashtra, India
Government Medical College and Super Speciality Hospital, Nagpur
Nagpur, Maharashtra, India
IMS and SUM Hospital
Bhubaneswar, Odisha, India
S.C.B. Medical College
Cuttack, Odisha, India
Christian Medical College Hospital, Vellore
Ranipet, Tamil Nadu, India
Christian Medical College Hospital, Vellore
Vellore, Tamil Nadu, India
Yashoda hospital
Hyderabad, Telangana, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India
NRS Medical College & Hospital
Kolkata, West Bengal, India
NRS Medical College & Hospital
Kolkata, West Bengal, India
KIMS - Kingsway Hospital
Nagpur, India
Ospedali Galliera
Genova, Italy
Fondazione IRCSS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Azienda Ospedale Universita Padova
Padova, Italy
Azienda Ospedaliera Universitaria Integrata Verona Policlinico GB Rossi - Borgo Roma
Verona, Italy
Policlinico GB Rossi
Verona, Italy
Abdali Hospital
Amman, Jordan
Istiklal Hospital
Amman, Jordan
The Specialty Hospital, Advanced Clinical Center
Amman, Jordan
Irbid Specialty Hospital Clinical Research Center
Irbid, Jordan
King Abdullah University Hospital
Irbid, Jordan
Hospital Nini
Tripoli, Lebanon
Sultan Qaboos University Hospital
Muscat, Sultanet of Oman/Muscat/Al Khoud, Oman
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Johannesburg, Gauteng, South Africa
Hospital Universitario La Paz
Madrid, Spain
Hospital Regional Universitario de Málaga
Málaga, Spain
Universitätsspital Zürich - Klinik für Medizinische Onkologie und Hämatologie
Zurich, Switzerland
Acıbadem Adana Hastanesi-Hematoloji
Adana, Turkey (Türkiye)
Çukurova Üniversitesi Tıp Fakültesi Balcalı Hastanesi- Hematoloji
Adana, Turkey (Türkiye)
Hacettepe Üniversitesi Hastanesi- Hematoloji
Ankara, Turkey (Türkiye)
Mersin Üniversitesi Tip Fakültesi Hastanesi- Çiftlikköy Yerleşkesi- Hematoloji
Mersin, Turkey (Türkiye)
University Hospital of Wales
Cardiff, United Kingdom
Royal London Hospital_London
London, United Kingdom
University College Hospital - Paediatric Services
London, United Kingdom
Central Middlesex Hospital
London, United Kingdom
Guy's Hospital
London, United Kingdom
King's College Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom