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

NCT01715779 | Completed

• 3 other identifiers: 116951WWE116951EPI40685
• Study Type: observational
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hepatitis C

Keywords

Liver transplantation; ENABLE; observational; mortality; Thromboembolic Events; Hepatic decompensation; Long-Term follow-up; TEE

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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.

Study Arms (1)

Patients who experienced a thromboembolic event

Patients who experienced a thromboembolic event during participation in the ENABLE clinical trials.

Drug: Eltrombopag

Interventions

Eltrombopag DRUG

Eltrombopag exposure

Patients who experienced a thromboembolic event

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• Novartis: lead

MeSH Terms

Conditions

Hepatitis C; Thromboembolism

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2012
• First Posted: October 29, 2012
• Study Start: August 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: April 8, 2016

Record last verified: 2016-04