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NCT05405114 · ClinicalTrials.gov registry record · Phase 2
Research Study Investigating How Well NDec Works in People With Sickle Cell Disease
A Phase 2 study, sponsored by Novo Nordisk A/S.
- Completed
- Registry status
- Phase 2
- Development phase
- 96
- Enrollment target
NCT05405114 is a Phase 2 study that has completed, run by Novo Nordisk A/S. The registered enrollment target is 96 participants.
The verdict
NCT05405114, a Phase 2 study, has completed, sponsored by Novo Nordisk A/S.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 96 participants
- Enrollment target
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.
Interventions
- DRUG Placebo
- DRUG NDec - oral decitabine-tetrahydrouridine
- DRUG HU - Hydroxyurea
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 96 participants |
| Start Date | 2022-07-07 |
| Est. Completion | 2025-07-24 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05405114
The ClinicalTrials.gov registry entry for NCT05405114 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 96 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novo Nordisk A/S, which has 431 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05405114 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05405114 about?
NCT05405114 is a clinical study titled "Research Study Investigating How Well NDec Works in People With Sickle Cell Disease". 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 Hydrox...
What is the current status of trial NCT05405114?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 96 participants. The study started on 2022-07-07. Estimated completion is 2025-07-24.
What interventions are being tested in trial NCT05405114?
The interventions under investigation include: Placebo (DRUG), NDec - oral decitabine-tetrahydrouridine (DRUG), HU - Hydroxyurea (DRUG).
Who is sponsoring clinical trial NCT05405114?
This trial is sponsored by Novo Nordisk A/S, which has 431 total clinical trials registered on ClinicalTrials.gov.
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