At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 44 enrolled
Drug / intervention
Azacitidinedrug
Likely dose
Azacitidine 75 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 4, Open-Label, Single-Arm Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous Azacitidine in Adult Taiwanese Subjects With Higher-Risk Myelodysplastic Syndromes.
In Brief
A Phase 4 clinical trial evaluating Azacitidine for Myelodysplastic Syndromes. Completed, enrolled 44 participants across 11 sites.
Detailed Summary
The primary purpose of this study is to determine the effectiveness and safety of azacitidine in the treatment of Taiwanese subjects with higher-risk Myelodysplastic Syndrome (MDS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMyelodysplastic Syndromes
CountriesTaiwan
Collaborators--
Timeline
Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2010
Enrollment StartOct 2010
Primary CompletionMay 2013
TodayJul 2026
First PostedSep 15, 2010
Enrollment StartOct 1, 2010
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 15.8 years ago
Interventions
Azacitidinedrug
Subjects will receive azacitidine 75 mg/m2/day SC for 7 days every 28 days for up to 6 cycles, unless they are discontinued from the treatment. In addition, subjects may receive best supportive care as needed, including antibiotics and transfusions, per Investigator discretion.