Follow-up Study of Patients Who Experienced Thromboembolic Events in the ENABLE Studies

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-06-30

Brief Summary

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The objective of this observational study is to characterize long-term (5 years post event) clinical outcomes in patients who experienced a thromboembolic event (TEE) during participation in the GSK ENABLE clinical trials.

Patients eligible for the study are patient who experienced a TEE during participation in the ENABLE trials. Each included patient will be followed for a period of 5 years from the date of their first TEE. Demographic and clinical characteristics will be collected for the index date (time of TEE) and every sixth month during the follow-up period, information will be collected for the outcomes of interests: mortality, new TEE, hepatic decompensation, evaluation for liver transplant and result of evaluation, and liver transplantation.

All information will collected by medical record review.

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients who experienced a thromboembolic event

Patients who experienced a thromboembolic event during participation in the ENABLE clinical trials.

Eltrombopag

Intervention Type DRUG

Eltrombopag exposure

Interventions

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Eltrombopag

Eltrombopag exposure

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with portal vein thrombosis (PVT)
* Patients with deep vein thrombosis (DVT)
* Patients with pulmonary embolism (PE)
* Patients with myocardial infarction (MI)
* Patients with unstable angina
* Patients with transient ischemic attack (TIA)
* Patients with ischemic stroke
* Patients with other TEE including embolism, thrombosis, phlebitis, and thrombophlebitis at other locations

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No