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NCT01011283 · ClinicalTrials.gov registry record · Phase 4
To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.
A Phase 4 study, sponsored by Eisai.
- Terminated
- Registry status
- Phase 4
- Development phase
- 26
- Enrollment target
NCT01011283: Clinical Trial Phase 4 study, sponsored by Eisai.
NCT01011283 is a Phase 4 study that was terminated before completion, run by Eisai. The registered enrollment target is 26 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01011283, a Phase 4 study, was terminated before completion, sponsored by Eisai.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 26 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.
Primary Outcome
Based on Modified International Working Group Response Criteria for Altering Natural History of Myelodysplastic Syndromes. Complete Response: Bone marrow: ≤ 5% myeloblasts with normal maturation of all cell lines. Persistent dysplasia will be noted. Peripheral blood Hgb ≥ 11 g/dL; Platelets ≥ 100 X 10\^9/L; Neutrophils ≥ 1.0 X 10\^9/Lb; Blasts 0%. Marrow Complete Response: Bone marrow: ≤ 5% myeloblasts and decrease by ≥ 50% over pretreatment. Peripheral blood: if hematological improvement resp
Interventions
- DRUG azacitidine
- DRUG decitabine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2009-11 |
| Phase | Phase 4 |
Why NCT01011283 stopped before completion
NCT01011283 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which azacitidine is the first listed.
NCT01011283 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01011283 about?
NCT01011283 is a clinical study titled "To Demonstrate Superiority of Decitabine Over Azacitidine in Subjects With Intermediate- or High-risk MDS.". The purpose of this study is to compare the response of patients with Intermediate or High Risk myelodysplastic syndromes (MDS) following treatment with decitabine or azacitidine.
What is the current status of trial NCT01011283?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 26 participants. The study started on 2009-11.
What interventions are being tested in trial NCT01011283?
The interventions under investigation include: azacitidine (DRUG), decitabine (DRUG).
Who is sponsoring clinical trial NCT01011283?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01011283's enrollment target sits among peer trials
26 1655th of 2000 higher than 332 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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