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Completed Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT05405114

Public ClinicalTrials.gov record NCT05405114. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 20, 2026, 3:17 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT05405114
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novo Nordisk A/S
Industry
Enrollment
96 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 7, 2022 (Actual)
Primary completion
Jul 24, 2025 (Actual)
Completion
Jul 24, 2025 (Actual)
Last update posted
Jul 22, 2026

2022 – 2025

United States locations

U.S. sites
53
U.S. states
27
U.S. cities
40
Facility City State ZIP Site status
University Of South Alabama Mobile Alabama 36617 —
Keck Medical Center of USC - Outpatient Clinic Los Angeles California 90033 —
UCSF Oakland Benioff ChildHosp Oakland California 94609 —
Center for Inherited Blood Dis Orange California 92868 —
Harbor-UCLA Medical Center Torrance California 90502-2004 —
Clinical and Transl Res Center Aurora Colorado 80045 —
Carole&Ray Neag Comp S.C. Ctr Farmington Connecticut 06030 —
Tova Community Health Inc Wilmington Delaware 19805 —
Howard University Hospital Department Med Washington D.C. District of Columbia 20060 —
Howard University Washington D.C. District of Columbia 20060 —
Foundation for Sickle Cell Disease Research Hollywood Florida 33023 —
University of Florida, College of Medicine Jacksonville Jacksonville Florida 32209 —
University of Miami Hospital & Clinics Miami Florida 33136 —
Emory University School Of Med Atlanta Georgia 30333 —
Aflac Cancer/Blood Dis CCH Atlanta Georgia 30342 —
Emory University School Of Med Atlanta Georgia 30342 —
Augusta University Augusta Georgia 30912 —
Rush University Med. Cntr Chicago Illinois 60612 —
Univer Of Illinois at Chicago Chicago Illinois 60612 —
Tulane Sickle Cell Ctr- So LA Metairie Louisiana 70002 —
Mass General Cancer Center Boston Massachusetts 02114 —
Wayne State University/University Health Center Detroit Michigan 48201 —
Children's Hospitals And Clinics Of Minnesota Minneapolis Minnesota 55404 —
University of Minnesota_Minneapolis_0 Minneapolis Minnesota 55455 —
Mississippi Center Advanced Medicine Madison Mississippi 39110 —
Univ of NE Med Center_Omaha Omaha Nebraska 68198 —
Cure 4 the Kids Foundation Las Vegas Nevada 89135 —
Hackensack University Medical Center Hackensack New Jersey 07601 —
Interfaith Medical Center Brooklyn New York 11238 —
Queens Hospital Center Jamaica New York 11432-1121 —
Mount Sinai School of Medicine New York New York 10029 —
Jacobi Medical Center The Bronx New York 10461 —
Montefiore Medical Center The Bronx New York 10467 —
University of North Carlolina-Chapel Hill Chapel Hill North Carolina 27599 —
Atrium Levine Children's/Atrium Health Charlotte North Carolina 28204 —
Duke Comprehen Sickle Cell Durham North Carolina 27710 —
East Carolina Univ-Greenville Greenville North Carolina 27834-4300 —
East Carolina Univ-Greenville Greenville North Carolina 27834 —
Dayton Children's Hosptial Dayton Ohio 45404 —
Univ Oklahoma HSC_Okla City Oklahoma City Oklahoma 73104 —
University of Oklahoma Health Sciences Center_Oklahoma City Oklahoma City Oklahoma 73104 —
Penn Comprehensive Hemophilia & Thrombosis Program Philadelphia Pennsylvania 19104 —
Thomas Jefferson University Hospital Philadelphia Pennsylvania 19107 —
St Christopher Hosp for Child Philadelphia Pennsylvania 19134 —
Hemophilia Center of Western PA Pittsburgh Pennsylvania 15213 —
Medical Univ of SC Charleston Charleston South Carolina 29425 —
University Of Tennessee Memphis Tennessee 38163 —
Baylor College of Medicine Texas Childen's Hospital Houston Texas 77030 —
Baylor College of Medicine_Houston Houston Texas 77030 —
Dan L. Duncan Comprehensive Cancer Center Houston Texas 77030 —
Univ Texas HSC-Houston Houston Texas 77030 —
University Of Virginia Hospital Charlottesville Virginia 22908 —
Medical College of Wisconsin & Zablocki VAMC Milwaukee Wisconsin 53226 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 65 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT05405114, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 22, 2026 · Synced Oct 20, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05405114 live on ClinicalTrials.gov.

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