Persistence, Adherence and Clinical Effectiveness in Patients With Chronic Hepatitis B Viral Infection Treated With Entecavir in Real Life

Bristol-Myers Squibb1 site in 1 country230 target enrollmentJanuary 2011

ConditionsHepatitis B, Chronic

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hepatitis B, Chronic
Sponsor: Bristol-Myers Squibb
Enrollment: 230
Locations: 1
Primary Endpoint: Percentage of Chronic hepatitis B (CHB) patients treated with Entecavir (ETV) and any switch or add-on therapy who are persistent over a time period of two years in a real-life setting.
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this observational study is to measure the real-life persistence, adherence and clinical effectiveness of entecavir in patients with chronic Hepatitis B viral infection.

Detailed Description

Sampling Method: Probability Sample (consecutive patient sampling)

Registry

clinicaltrials.gov

Start Date

January 2011

End Date

January 2015

Last Updated

10 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Bristol-Myers Squibb

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male and female treatment naïve or pre-treated CHB patients of at least 18 years of age
•Written informed consent

Exclusion Criteria

•All relevant conditions according to Summary of product characteristics (SmPC)
•Human immunodeficiency virus (HIV), Hepatitis C virus (HCV) or Hepatitis D virus (HDV) co-infection
•Patients currently included in any investigational trial on CHB

Outcomes

Primary Outcomes

Percentage of Chronic hepatitis B (CHB) patients treated with Entecavir (ETV) and any switch or add-on therapy who are persistent over a time period of two years in a real-life setting.

Time Frame: After 2 years

A patient will be defined as non-persistent if he misses all his doses in more than 30 subsequent days or if he fails to show up at more than one subsequent visit.

Secondary Outcomes

Reasons for therapy non-persistence (therapy discontinuation) and low therapy adherence (qualitative questionnaire for causal assessment of non-persistence/non-adherence)(After 2 years)
Number of participants with occuring resistances based on results from resistance tests(After 2 years)
Assessment of Health Status (SF-12® Health Survey)(Assessment of Health Status (SF-12 Health Survey) at year 2)
Adherence rates using administrative measures (continuous multiple-interval medication gaps, continuous single interval medication availability), and self-report measures, 8-item self-report Morisky Medication Adherence Scale (MMAS)(After 2 years)
Proportion of patients with HBV DNA below the limit of detection (according to local lab standard), mean log reduction of HBV DNA from baseline, proportion of subjects with normal ALT and with e antigen (eAg)/Surface antigen (sAg) seroconversion/loss(After 2 years)
Frequency of Serious adverse drug reaction ((S)ADR)s and study discontinuations due to (S)ADRs(After 2 years)