Drug Use Investigation for REVOLADE (ITP)

November 18, 2020 updated by: Novartis Pharmaceuticals

Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5797

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All Japanese subjects with chronic idiopathic thrombocytopenic purpura who recieve REVOLADE

Description

Inclusion Criteria:

  • Subjects with chronic idiopathic thrombocytopenic purpura

Exclusion Criteria:

  • Not applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Subjects prescribed REVOLADE
Subjects with chronic idiopathic thrombocytopenic purpura prescribed REVOLADE during study period
Drug: Eltrombopag

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The number of subjects with any adverse events treated with REVOLADE
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 21, 2010

Primary Completion (ACTUAL)

October 16, 2020

Study Completion (ACTUAL)

October 16, 2020

Study Registration Dates

First Submitted

June 9, 2011

First Submitted That Met QC Criteria

August 11, 2011

First Posted (ESTIMATE)

August 15, 2011

Study Record Updates

Last Update Posted (ACTUAL)

November 20, 2020

Last Update Submitted That Met QC Criteria

November 18, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114877
  • CETB115B1401 (OTHER: Novartis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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