Study Complete
Sponsor ID
20080435
Interventional Study in Adults with Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim
Study Details
The purpose of this study is to describe the number of months with a platelet response over a 12 month treatment period and to describe ITP remission rates in adults with ITP receiving romiplostim.
Protocol Summary
Primary Outcome Measures
Number of Months with Platelet Response During the 12-Month Treatment Period
Timeframe: 12 months
Secondary Outcome Measures
Percentage of Participants with ITP Remisssion
Timeframe: Up to 24 months
Percentage of Participants with Splenectomy During the 12-month Treatment Period
Timeframe: 12 months
Number of Participants with Adverse Events
Timeframe: From first dose date of romiplostim to end of study (up to 24 months).
Number of Participants who Developed Antibodies to Romiplostim
Timeframe: Baseline and at end of treatment (based on response to treatment, this could occur between 12 months and approximately 18 months)
Study Documents
Study Synopsis
Available Language(s): English
Locations
Location
Research Site
Praha 10, Czech Republic, 100 34
Status
Completed
Location
Research Site
Brno, Czech Republic, 625 00
Status
Completed
Location
Research Site
Ostrava-Poruba, Czech Republic, 708 52
Status
Completed
Location
Research Site
Praha 2, Czech Republic, 128 08
Status
Recruiting
Location
Research Site
Pessac Cedex, France, 33604
Status
Completed
Location
Research Site
Bondy Cedex, France, 93143
Status
Completed
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