Drug Use Investigation for REVOLADE (ITP)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
ClinicalTrials.gov Identifier:
First received: June 9, 2011
Last updated: July 9, 2015
Last verified: July 2015

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

Condition Intervention
Purpura, Thrombocytopaenic, Idiopathic
Drug: Eltrombopag

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Drug Use Investigation for REVOLADE (Chronic Idiopathic Thrombocytopenic Purpura)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • The number of subjects with any adverse events treated with REVOLADE [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Appearance of thromboembolism [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    If thromboembolism is appeared or not in subjects who recieved REVOLADE will be investigated throughout the study period

Estimated Enrollment: 1000
Study Start Date: December 2010
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Subjects prescribed REVOLADE
Subjects with chronic idiopathic thrombocytopenic purpura prescribed REVOLADE during study period
Drug: Eltrombopag


Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All Japanese subjects with chronic idiopathic thrombocytopenic purpura who recieve REVOLADE

Inclusion Criteria:

  • Subjects with chronic idiopathic thrombocytopenic purpura

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01416311

Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01416311     History of Changes
Other Study ID Numbers: 114877 
Study First Received: June 9, 2011
Last Updated: July 9, 2015
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Diseases
Blood Coagulation Disorders
Blood Platelet Disorders
Hematologic Diseases
Hemorrhagic Disorders
Immune System Diseases
Pathologic Processes
Signs and Symptoms
Skin Manifestations
Thrombotic Microangiopathies

ClinicalTrials.gov processed this record on February 07, 2016