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

Purpose

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.

Condition	Intervention
Hepatitis C	Drug: Eltrombopag

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	An Observational Follow-up Study of Patients Who Experienced Thromboembolic Events in the ENABLE Studies

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis C Liver Transplantation

Drug Information available for: Eltrombopag

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Mortality. Patients who experience a thromboembolic event (TEE) and died during study participation. [ Time Frame: The patients will be followed from 5 years from first occurrence of thromboembollic event. ] [ Designated as safety issue: Yes ]
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. [ Time Frame: The patients will be followed from 5 years from first occurrence of thromboembollic event. ] [ Designated as safety issue: Yes ]
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. [ Time Frame: The patients will be followed from 5 years from first occurrence of thromboembollic event. ] [ Designated as safety issue: Yes ]
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. [ Time Frame: The patients will be followed from 5 years from first occurrence of thromboembollic event. ] [ Designated as safety issue: Yes ]
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. [ Time Frame: The patients will be followed from 5 years from first occurrence of thromboembollic event. ] [ Designated as safety issue: Yes ]
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.

Estimated Enrollment:	1
Study Start Date:	August 2012
Estimated Study Completion Date:	January 2015
Estimated Primary Completion Date:	January 2015 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients who experienced a thromboembolic event Patients who experienced a thromboembolic event during participation in the ENABLE clinical trials.	Drug: Eltrombopag Eltrombopag exposure

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01715779

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01715779 History of Changes
Other Study ID Numbers:	116951, WWE116951, EPI40685
Study First Received:	October 25, 2012
Last Updated:	October 25, 2012
Health Authority:	United States: No Health Authority

Keywords provided by GlaxoSmithKline:

Liver transplantation
ENABLE
observational
mortality

Thromboembolic Events
Hepatic decompensation
Long-Term follow-up
TEE

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis C
Thromboembolism
Embolism
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases

Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

ClinicalTrials.gov processed this record on May 22, 2013