Study Complete
Sponsor ID
20080435

Interventional Study in Adults with Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim

Sponsor ID
20080435
Clinicaltrials.gov ID
NCT01143038
EUCTIS ID
N/A
EudraCT ID
2010-019987-35

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.

Additional Study Details

Phase
Phase 2
Product
romiplostim
Type
Interventional
Masking
None (Open Label)
Enrollment
75
Additional Study Details

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
Status
Contact Us
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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