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Drug Use Investigation for REVOLADE (ITP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01416311
First received: June 9, 2011
Last updated: August 11, 2011
Last verified: August 2011
History of Changes
  Purpose

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
Chronic Idiopathic Thrombocytopenic Purpura
 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:

Drug Information available for: Eltrombopag
U.S. FDA Resources

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: March 2016
Estimated Primary Completion Date: December 2015 (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

  Eligibility

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

Criteria

Inclusion Criteria:

  • Subjects with chronic idiopathic thrombocytopenic purpura

Exclusion Criteria:

  • Not applicable
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01416311

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

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01416311     History of Changes
Other Study ID Numbers: 114877
Study First Received: June 9, 2011
Last Updated: August 11, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

ClinicalTrials.gov processed this record on May 16, 2013