WEUSKOP7135: A prospective, observational cohort study nested within the HCV TARGET study to evaluate real-world use (201110)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Disease epidemiology

  Effectiveness study (incl. comparative)
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  ELTROMBOPAG
• Medical condition to be studied:
  Hepatitis C

Population studied

• Short description of the study population:
  Patients with chronic hepatitis C virus infection who receive eltrombopag therapy with interferon-based therapy that also includes direct acting anti-viral agents.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired
• Estimated number of subjects:
  58

Study design details

• Main study objective:
  The aim of this study is to report the incidence of hepatic decompensation among eltrombopag users with chronic hepatitis C virus infection who are unable to initiate or maintain optimal interferon-based therapy due to thrombocytopenia.
• Outcomes:
  The aim of this study is to report the incidence of hepatic decompensation among eltrombopag users with chronic hepatitis C virus infection who are unable to initiate or maintain optimal interferon-based therapy due to thrombocytopenia. Secondary objectives include reporting incidence of thromboembolic events and mortality and identifying risk factors for hepatic decompensation, thromboembolic events and mortality among eltrombopag users in a real-world setting. The study will also report the 3- year incidence of hepatic decompensation and mortality, and examine effectiveness of eltrombopag to initiate and maintain HCV therapy.
• Data analysis plan:
  Cumulative incidence rates and corresponding 95% confidence intervals as well as Kaplan-Meier rates and corresponding 95% confidence intervals will be calculated for the occurrence of hepatic decompensation, thromboembolic events, or mortality, as separate events, at multiple time points during and at the end of the 3-year followup period. Baseline factors potentially predictive of events will be identified through Kaplan-Meier survival estimates for patients with vs. without the factor and testing for statistical significance using the log-rank test. Cox proportional hazards models will be constructed to evaluate the influence of these identified factors simultaneously.

Documents

Study results

ETB115A2408-CSR_Redacted