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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01715779

Enrollment

Registered

2012-10-29

Start date

2012-08-31

Completion date

2015-06-30

Last updated

2016-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Liver transplantation, ENABLE, observational, mortality, Thromboembolic Events, Hepatic decompensation, Long-Term follow-up, TEE

Brief summary

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.

Interventions

DRUGEltrombopag

Eltrombopag exposure

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026