Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00321711
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2006-05-02
Brief Title:
Determination of Safe and Effective Dose of Romiplostim AMG 531 in Subjects With Myelodysplastic Syndrome MDSReceiving Hypomethylating Agents
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
A Randomized Double Blind Placebo Controlled Study Evaluating the Efficacy and Safety of Romiplostim AMG 531 Treatment of Subjects With Low or Intermediate Risk Myelodysplastic Syndrome MDS Receiving Hypomethylating Agents
Status:
COMPLETED
Status Verified Date:
2018-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effect of Romiplostim AMG 531 on the incidence of clinically significant thrombocytopenic events grade 3 or 4 andor receipt of platelet transfusions in subjects with low or intermediate risk Myelodysplastic Syndrome MDS receiving hypomethylating agents It is hypothesized that Romiplostim administration at the appropriate dose and schedule will result in reduction in the incidence of clinically significant thrombocytopenic events in low or intermediate risk MDS subjects receiving hypomethylating agents
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None