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

A Multicentre Trial Evaluating the Efficacy and Safety of Oral Decitabine Tetrahydrouridine (NDec) in Patients With Sickle Cell Disease

NCT05405114•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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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:
+3 more criteria

Locations (69)

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

Key Dates

Start Date

July 7, 2022

Primary Completion Date

July 24, 2025

Completion Date

July 24, 2025

Last Updated

December 30, 2025

Enrollment

ACTUAL participants

Conditions

Sickle Cell Disease

Interventions

NDec - oral decitabine-tetrahydrouridine

DRUG

HU - Hydroxyurea

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Dietary Intake and Dietary Behaviors in Adults With Sickle Cell Disease

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