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

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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Key information

Conditions

Hepatitis C Blood-Borne Infections Cardiovascular Diseases Communicable Diseases Digestive System Diseases Embolism and Thrombosis Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Thromboembolism Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

There are no exclusion criteria for this study

Treatment and study plan

eltrombopag

Drug

Eltrombopag exposure

Primary outcomes

Mortality. Patients who experience a thromboembolic event (TEE) and died during study participation.

Time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.

An observational study following patients who experienced a thromboembolic event (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. All information will collected by medical record review.
New Thromboembolic Events (TEE). Patients who experienced a new TEE during participation.

Time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.

An observational study following patients who experienced a thromboembolic event (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. All information will collected by medical record review.
Hepatic decompensation. Patients who experienced a hepatic decompensation during study participation.

Time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.

An observational study following patients who experienced a thromboembolic event (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. All information will collected by medical record review.
Evaluation for liver transplant and result of evaluation.

Time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.

An observational study following patients who experienced a thromboembolic event (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. All information will collected by medical record review.
Liver transplantation. Patients who experienced a Liver transplantation during study participation.

Time frame: The patients will be followed from 5 years from first occurrence of thromboembolic event.

An observational study following patients who experienced a thromboembolic event (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. All information will collected by medical record review.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

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

Important dates

Study start: 2012
Primary completion: 2015
Study completion: 2015
First posted: Oct 29, 2012
Registry last updated: Apr 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed