NCT01416311

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,797

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 21, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 15, 2011

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2020

Completed
Last Updated

November 20, 2020

Status Verified

November 1, 2020

Enrollment Period

9.8 years

First QC Date

June 9, 2011

Last Update Submit

November 18, 2020

Conditions

Purpura, Thrombocytopaenic, Idiopathic

Outcome Measures

Primary Outcomes (1)

  • The number of subjects with any adverse events treated with REVOLADE

    1 year

Secondary Outcomes (1)

  • Appearance of thromboembolism

    1 year

Study Arms (1)

Subjects prescribed REVOLADE

Subjects with chronic idiopathic thrombocytopenic purpura prescribed REVOLADE during study period

Drug: Eltrombopag

Interventions

EltrombopagDRUG
Subjects prescribed REVOLADE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All Japanese subjects with chronic idiopathic thrombocytopenic purpura who recieve REVOLADE

You may qualify if:

  • Subjects with chronic idiopathic thrombocytopenic purpura

You may not qualify if:

  • Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Purpura

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Study Officials

  • Novartis Pharmaceuticals

    Novartis Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2011

First Posted

August 15, 2011

Study Start

December 21, 2010

Primary Completion

October 16, 2020

Study Completion

October 16, 2020

Last Updated

November 20, 2020

Record last verified: 2020-11