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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01715779
First received: October 25, 2012
Last updated: April 6, 2016
Last verified: April 2016
  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:


Further study details as provided by Novartis:

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 thromboembolic 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 thromboembolic 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 thromboembolic 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 thromboembolic 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 thromboembolic 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.


Enrollment: 22
Study Start Date: August 2012
Study Completion Date: June 2015
Primary Completion Date: June 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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01715779     History of Changes
Other Study ID Numbers: 116951  WWE116951  EPI40685 
Study First Received: October 25, 2012
Last Updated: April 6, 2016
Health Authority: United States: No Health Authority

Keywords provided by Novartis:
Liver transplantation
ENABLE
observational
mortality
Thromboembolic Events
Hepatic decompensation
Long-Term follow-up
TEE

Additional relevant MeSH terms:
Hepatitis C
Thromboembolism
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 23, 2016