Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Oakland, California and other locations
Dates
study started
completion around

Description

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.

Official Title

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

Keywords

Sickle Cell Disease, Sickle Cell Anemia, Decitabine, Hydroxyurea, Tetrahydrouridine, NDec - oral decitabine-tetrahydrouridine, HU - Hydroxyurea, HU-non-eligible - NDec plus NDec

Eligibility

Locations

  • UCSF Oakland Benioff Children's Hospital not yet accepting patients
    Oakland California 94609 United States
  • Harbor-UCLA Medical Center accepting new patients
    Torrance California 90502-2004 United States
  • Cure 4 the Kids Foundation accepting new patients
    Las Vegas Nevada 89135 United States

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Novo Nordisk A/S
ID
NCT05405114
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 84 study participants
Last Updated