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

Study Overview
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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.

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

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Eltrombopag


Participation Criteria
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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 Exclusion Criteria: There are no exclusion criteria for this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients who experienced a thromboembolic event<br>Patients who experienced a thromboembolic event during participation in the ENABLE clinical trials. | Drug: Eltrombopag<br>* Eltrombopag exposure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality. Patients who experience a thromboembolic event (TEE) and died during study participation. | 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. | The patients will be followed from 5 years from first occurrence of thromboembolic event. | 
| New Thromboembolic Events (TEE). Patients who experienced a new TEE during participation. | 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. | The patients will be followed from 5 years from first occurrence of thromboembolic event. | 
| Hepatic decompensation. Patients who experienced a hepatic decompensation during study participation. | 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. | The patients will be followed from 5 years from first occurrence of thromboembolic event. | 
| Evaluation for liver transplant and result of evaluation. | 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. | The patients will be followed from 5 years from first occurrence of thromboembolic event. | 
| Liver transplantation. Patients who experienced a Liver transplantation during study participation. | 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. | The patients will be followed from 5 years from first occurrence of thromboembolic event. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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observational, mortality, Thromboembolic Events, Hepatic decompensation, Long-Term follow-up, Liver transplantation, ENABLE, TEE