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

Novartis

Status

Completed

Conditions

Hepatitis C

Treatments

Drug: Eltrombopag

Study type

Observational

Funder types

Industry

Identifiers

NCT01715779

WWE116951 (Other Identifier)

116951

EPI40685 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

22 patients

Sex

All

Ages

18+ years old

Volunteers

No 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