Last updated: 11/03/2018 19:49:02
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.

An Observational Follow-up Study of Patients who Experienced Thromboembolic events in the ENABLE studies

GSK study ID
116951
Clinicaltrials.gov ID
NCT01715779
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An Observational Follow-up Study of Patients who Experienced Thromboembolic events in the ENABLE studies
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Liver transplantation. Patients who experienced a Liver transplantation during study participation.

Timeframe: The patients will be followed from 5 years from first occurrence of thromboembollic event.

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 thromboembollic event.

Evaluation for liver transplant and result of evaluation.

Timeframe: The patients will be followed from 5 years from first occurrence of thromboembollic event.

Hepatic decompensation. Patients who experienced a hepatic decompensation during study participation.

Timeframe: The patients will be followed from 5 years from first occurrence of thromboembollic event.

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 thromboembollic event.

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Eltrombopag
    • Enrollment:
    1
    Primary completion date:
    Not applicable
    Observational study model:
    Cohort
    Time perspective:
    Prospective
    Clinical publications:
    Not applicable
    Medical condition
    Hepatitis C
    Product
    eltrombopag
    Collaborators
    Not applicable
    Study date(s)
    August 2012 to March 2016
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    none
    • Patients with portal vein thrombosis (PVT)
    • Patients with deep vein thrombosis (DVT)
    • There are no exclusion criteria for this study
    Inclusion and exclusion 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

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    No study documents available.

    Results overview

    No study documents available

    Recruitment status
    No longer a GSK study
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
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