At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 35 enrolled
Drug / intervention
AMG531drug
Likely dose
Not stated in 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 2, Randomized, Open-Label, Parallel, Comparative, Dose-Finding Study to Evaluate the Efficacy and Safety of AMG531 in Aplastic Anemia Subjects With Thrombocytopenia Refractory to Immunosuppressive Therapy
In Brief
A Phase 2 clinical trial evaluating AMG531 for Aplastic Anemia. Completed, enrolled 35 participants across 1 site.
Detailed Summary
The present study will be conducted to evaluate the efficacy and safety of AMG531 and to determine the recommended initial dose of AMG531 on the basis of its efficacy and safety when it is administered subcutaneously (SC) to the Aplastic Anemia (AA) patients with immunosuppressive-therapy refractory thrombocytopenia and also to assess the pharmacokinetics of this product. Its efficacy and safety during the extension period beyond one year will also be evaluated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAplastic Anemia
CountriesSouth Korea
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartApr 2014
Primary CompletionApr 2017
Study CompletionNov 2017
TodayJul 2026
First PostedMar 21, 2014
Enrollment StartApr 14, 2014
Primary CompletionApr 24, 2017
Study CompletionNov 7, 2017
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 12.3 years ago
Interventions
AMG531drug
Subcutaneous, weekly injection