NCT01715779

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
• Phase: —
• Study type: Observational
• Enrollment: 22 (actual)
• Sponsor: Novartis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	Eltrombopag	Eltrombopag exposure

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-06-01
• Completion: 2015-06-01
• First posted: 2012-10-29
• Last updated: 2016-04-08