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Study identifier: NCT05405114 Synced from ClinicalTrials.gov · August 08, 2026
● Study status: CompletedASCENT1

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

Condition: Sickle Cell Disease  ·  Sponsor: Novo Nordisk A/S

PhasePhase 2
Planned participants96
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNoCheck eligibility criteria ↓
Where118 locations · 14 countries

Sponsor, CRO or site team? See where this study is running → — listed sites, countries and recruiting context. Everything below is written for patients and caregivers.

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

No contact information is available for this study as per the public registry record.

Always discuss trial participation with your own doctor first.

Full eligibility criteria (exactly as the study team wrote them)

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 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: * Patient is on chronic transfusion therapy as defined by receiving scheduled (pre-planned) series of blood transfusion (simple or exchange) for prophylactic purposes, or the patient is likely to begin chronic transfusion therapy during the course of the trial, or has received RBC or whole blood transfusion for any reason within 28 days of visit 1 * 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

Reproduced word-for-word from the public registry record — the study team can answer questions about it.

Locations (118)

University Of South AlabamaMobile, Alabama, United States
Keck Medical Center of USC - Outpatient ClinicLos Angeles, California, United States
UCSF Oakland Benioff ChildHospOakland, California, United States
Center for Inherited Blood DisOrange, California, United States
Harbor-UCLA Medical CenterTorrance, California, United States
Clinical and Transl Res CenterAurora, Colorado, United States
Carole&Ray Neag Comp S.C. CtrFarmington, Connecticut, United States
Tova Community Health IncWilmington, Delaware, United States
Howard University Hospital Department MedWashington D.C., District of Columbia, United States
Howard UniversityWashington D.C., District of Columbia, United States
Foundation for Sickle Cell Disease ResearchHollywood, Florida, United States
University of Florida, College of Medicine JacksonvilleJacksonville, Florida, United States

+ 106 more locations — full list on the registry record.

More studies in these areas

This study lists sites in the areas below. Each link shows other recruiting studies near that city, from the public registry record.

MobileLos AngelesOaklandOrange

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