Drug Use Investigation for REVOLADE (ITP)

Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01416311

Enrollment

5797

Registered

2011-08-15

Start date

2010-12-21

Completion date

2020-10-16

Last updated

2020-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Purpura, Thrombocytopaenic, Idiopathic

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

Interventions

DRUGEltrombopag

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Subjects with chronic idiopathic thrombocytopenic purpura

Exclusion criteria

* Not applicable

Design outcomes

Primary

Measure	Time frame
The number of subjects with any adverse events treated with REVOLADE	1 year

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026