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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01715779
• Other study ID #: 116951
• Secondary ID: WWE116951EPI4068
• Status: Completed
• Phase: N/A
• First received: October 25, 2012
• Last updated: April 6, 2016
• Start date: August 2012
• Est. completion date: June 2015

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: No Health Authority
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis C
• Thromboembolism

Intervention

Drug:
• Eltrombopag
Eltrombopag exposure

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes
Primary	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.	Yes
Primary	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.	Yes
Primary	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.	Yes
Primary	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.	Yes