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COMPLETED
NCT05405114
PHASE2

Research Study Investigating How Well NDec Works in People With Sickle Cell Disease

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

HU - Hydroxyurea

Participants will get capsules daily (oral administration) according to local labelling

DRUG

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