At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 250 enrolled
Drug / intervention
Placebo +1 moredrug
Likely dose
Placebo 5 mLfrom 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 Randomized, Double Blind, Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim Treatment of Thrombocytopenia in Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
In Brief
A Phase 2 clinical trial evaluating Placebo and Romiplostim for MDS and 2 related conditions. Completed, enrolled 250 participants.
Detailed Summary
The Data Monitoring Committee (DMC) for study 20060198 recommended that all subjects discontinue treatment of study drug and continue to be followed for long term follow-up. Amgen adopted the DMC recommendation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMDS, Myelodysplastic Syndromes, Thrombocytopenia
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 2008
Enrollment StartJul 2008
Primary CompletionMar 2011
Study CompletionNov 2015
TodayJul 2026
First PostedFeb 13, 2008
Enrollment StartJul 21, 2008
Primary CompletionMar 31, 2011
Study CompletionNov 30, 2015
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 18.4 years ago
Interventions
Placebodrug
Placebo is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.
Romiplostimbiological
Romiplostim is supplied in a 5 mL single use glass vial as a sterile, white, preservative-free, lyophilized powder.