Drug Use Investigation for REVOLADE (ITP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01416311
First received: June 9, 2011
Last updated: July 3, 2014
Last verified: June 2013
  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
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: 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01416311     History of Changes
Other Study ID Numbers: 114877
Study First Received: June 9, 2011
Last Updated: July 3, 2014
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 July 20, 2014