Drug Use Investigation for REVOLADE (ITP)

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

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Key information

Conditions

Purpura, Thrombocytopaenic, Idiopathic Blood Coagulation Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Signs and Symptoms Skin Manifestations

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects with chronic idiopathic thrombocytopenic purpura

Exclusion criteria

Not applicable

Treatment and study plan

eltrombopag

Drug

Primary outcomes

The number of subjects with any adverse events treated with REVOLADE

Time frame: 1 year

Secondary outcomes

Appearance of thromboembolism

Time frame: 1 year

If thromboembolism is appeared or not in subjects who received REVOLADE will be investigated throughout the study period

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)

Important dates

Study start: 2010
Primary completion: 2020
Study completion: 2020
First posted: Aug 15, 2011
Registry last updated: Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed