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

NCT05405114 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 96

Last updated 2025-12-30

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (dept. 2834) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-07
Primary Completion
2025-07-24
Completion
2025-07-24
FDA Drug
Yes

Countries

  • United States
  • Canada
  • France
  • Greece
  • India
  • Italy
  • Lebanon
  • Oman
  • South Africa
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05405114 on ClinicalTrials.gov