Clinical trial NCT01715779: Follow-up Study of Patients Who Experienced Thromboembolic Events in the ENABLE Studies
Official title: An Observational Follow-up Study of Patients Who Experienced Thromboembolic Events in the ENABLE Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: Liver transplantation
ENABLE
observational
mortality
Thromboembolic Events
Hepatic decompensation
Long-Term follow-up
TEE
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-10-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients under study are patients who experienced a thromboembolic event during participation in the ENABLE clinical trials.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mortality. Patients who experience a thromboembolic event (TEE) and died during study participation.
timeFrame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
measure: New Thromboembolic Events (TEE). Patients who experienced a new TEE during participation.
timeFrame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
measure: Hepatic decompensation. Patients who experienced a hepatic decompensation during study participation.
timeFrame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
measure: Evaluation for liver transplant and result of evaluation.
timeFrame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
measure: Liver transplantation. Patients who experienced a Liver transplantation during study participation.
timeFrame: The patients will be followed from 5 years from first occurrence of thromboembolic event.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: