Drug Use Investigation for REVOLADE (ITP)

Completed

• Conditions: Purpura, Thrombocytopaenic, Idiopathic
• Interventions: Drug: Eltrombopag

• Registration Number: NCT01416311
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

To investigate safety and efficacy in the actual use of REVOLADE collected from all subjects receiving the drug until data from a specified number of subjects are accumulated to identify factors considered to influence its safety and efficacy.

\<Priority investigation item\> Thromboembolism

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-21
• Study First Submitted: 2011-06-09
• Study First Submitted QC: 2011-08-11
• Study First Posted: 2011-08-15
• Primary Completion: 2020-10-16
• Study Completion: 2020-10-16
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5797

Inclusion Criteria

• Subjects with chronic idiopathic thrombocytopenic purpura

Exclusion Criteria

• Not applicable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects prescribed REVOLADE	Eltrombopag	Subjects with chronic idiopathic thrombocytopenic purpura prescribed REVOLADE during study period

Primary Outcome Measures

Name	Time	Method
The number of subjects with any adverse events treated with REVOLADE	1 year

Secondary Outcome Measures

Name	Time	Method
Appearance of thromboembolism	1 year	If thromboembolism is appeared or not in subjects who received REVOLADE will be investigated throughout the study period