Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472290
Status:
COMPLETED
Last Update Posted:
2017-12-29
First Post:
2007-05-10
Brief Title:
Evaluating the Safety of Long Term Dosing of Romiplostim Formerly AMG 531 in Thrombocytopenic Subjects With Myelodysplastic Syndromes MDS
Sponsor:
Amgen
Organization:
Amgen
Study Overview
Official Title:
An Open Label Extension Study Evaluating the Safety of Long Term Dosing of Romiplostim in Thrombocytopenic Subjects With Myelodysplastic Syndromes MDS
Status:
COMPLETED
Status Verified Date:
2017-12
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:
This is an open label extension study of romiplostim for treatment of thrombocytopenia platelet count 50 x 109L in MDS subjects The study is designed to assess the long-term safety of treatment with romiplostim as measured by incidence of overall adverse events the incidence of bleeding events the utilization of platelet transfusions and the duration of platelet response The study will further describe the time to disease progression to acute myeloid leukemia AML and survival
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