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

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Eltrombopag

• Registration Number: NCT01715779
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-10-25
• Study First Submitted QC: 2012-10-25
• Study First Posted: 2012-10-29
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-06
• Last Update Posted: 2016-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients who experienced a thromboembolic event	Eltrombopag	Patients who experienced a thromboembolic event during participation in the ENABLE clinical trials.

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.