Research Study Investigating How Well NDec Works in People With Sickle Cell Disease
NCT ID: NCT05405114
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
96 participants
INTERVENTIONAL
2022-07-07
2025-07-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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HU-non-eligible - NDec plus placebo
HU-non eligible patients randomised to treatment with NDec on one day and placebo on the other day
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
Placebo
Participants will get capsules (oral administration) to take once or twice weekly. The number of capsules will be based on their body weight
HU-non-eligible - NDec plus NDec
HU-non eligible patients randomised to treatment with NDec on both days
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-non-eligible - Placebo plus placebo
HU-non eligible patients randomised to treatment with placebo on both days
Placebo
Participants will get capsules (oral administration) to take once or twice weekly. The number of capsules will be based on their body weight
HU-active - NDec plus placebo
HU-active patients randomised to treatment with NDec on one day and placebo on the other day
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
Placebo
Participants will get capsules (oral administration) to take once or twice weekly. The number of capsules will be based on their body weight
HU-active - NDec plus NDec
HU-active patients randomised to treatment with NDec on both days
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-active - HU
HU-active patients randomised to continue on open-label HU treatment
HU - Hydroxyurea
Participants will get capsules daily (oral administration) according to local labelling
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 months prior to the screening visit
* Haemoglobin greater than or equal to 5.0 g/dL and below or equal to 10.5 g/dL at visit 1
* Absolute reticulocyte count above upper limit of the normal (ULN) at visit 1
* Body weight 40 to 125 kg (inclusive).
Exclusion Criteria
* Receipt of erythropoietin or other haematopoietic growth factor treatment within 28 days of signing ICF, or planned treatment with these agents during the trial
* Receipt of voxelotor, crizanlizumab or L-glutamine treatment within 12 weeks of signing the informed consent form, or planned treatment with such agents during the trial
* 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 intestine which may affect drug absorption, as per investigator's judgement
* Female who is
* pregnant, breast-feeding or intends to become pregnant within 6 months after the final trial product administration
* child-bearing potential and not using highly effective methods of contraception and whose male partner is not using effective contraception, at screening and until 6 months after the last dose of trial product
* Male with female partner of childbearing potential who does not agree to use condom and whose female partner of childbearing potential is not using a highly effective contraceptive measure from trial start to:
* Six (6) months after the last dose of trial product for patients on NDec/Placebo
* Six (6) months after the last dose of trial product for patients outside US and CA randomised to HU
* Twelve (12) months after the last dose of trial product for patients randomised to HU in US and CA
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Transparency (dept. 2834)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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University Of South Alabama
Mobile, Alabama, United States
UCSF Oakland Benioff Children's Hospital
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
Howard University
Washington D.C., District of Columbia, United States
Foundation for Sickle Cell Disease Research
Hollywood, Florida, United States
University of Miami Hospital & Clinics
Miami, Florida, United States
University Of Illinois at Chicago
Chicago, Illinois, United States
Tulane Sickle Cell Ctr- So LA
Metairie, Louisiana, United States
Mississippi Center Advanced Medicine
Madison, Mississippi, United States
Cure 4 the Kids Foundation
Las Vegas, Nevada, United States
Mount Sinai School of Medicine
New York, New York, United States
Jacobi Medical Center
The Bronx, New York, United States
East Carolina Univ-Greenville
Greenville, North Carolina, 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
St Christopher Hosp for Child
Philadelphia, Pennsylvania, United States
Medical Univ of SC Charleston
Charleston, South Carolina, United States
Univ Texas HSC-Houston
Houston, Texas, United States
LHSC - Victoria Hospital
London, Ontario, Canada
Toronto General Hospital, Liver Clinic
Toronto, Ontario, Canada
Toronto General Hospital, Liver Clinic
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Centre Hospitalier Universitaire Grenoble Alpes-Site Nord Michallon-3
Grenoble, , France
Hospices Civils de Lyon-Hopital Edouard Herriot
Lyon, , 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
All India Institute of Medical Sciences (AIIMS), Raipur
Raipur, Chhattisgarh, 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
Padua, , Italy
Azienda Ospedaliera Universitaria Integrata Verona Policlinico GB Rossi - Borgo Roma
Verona, , Italy
Policlinico GB Rossi
Verona, , Italy
Hospital Nini
Tripoli, , Lebanon
Sultan Qaboos University Hospital
Muscat, , Oman
Charlotte Maxeke Johannesburg Academic Hospital
Parktown, Johannesburg, Gauteng, South Africa
Hospital Universitario La Paz
Madrid, , Spain
Hospital Regional Universitario de Málaga
Málaga, , Spain
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
Central Middlesex Hospital
London, , United Kingdom
Guy's Hosptial
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
Manchester Royal Infirmary
Manchester, , United Kingdom
Countries
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References
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Helleberg H, Bjornsdottir I, Offenberg HK. Effects of Tetrahydrouridine Pre-dosing on Absorption, Metabolism, and Excretion of Decitabine in the Mouse. Eur J Pharm Sci. 2025 Oct 27;216:107353. doi: 10.1016/j.ejps.2025.107353. Online ahead of print.
Abbasi M, Srivastava A, Saraf SL. Management of Kidney Disease with Sickle Cell Disease. J Am Soc Nephrol. 2025 Oct 1;36(10):2041-2054. doi: 10.1681/ASN.0000000804. Epub 2025 Jun 26.
Other Identifiers
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U1111-1255-1324
Identifier Type: OTHER
Identifier Source: secondary_id
2020-003485-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
NN7533-4470
Identifier Type: -
Identifier Source: org_study_id