Persistence, Adherence and Clinical Effectiveness of Entecavir in Chronic Hepatitis B Patients

July 3, 2015 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Sampling Method: Probability Sample (consecutive patient sampling)

Study Type

Observational

Enrollment (Actual)

230

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Herne, Germany, 44623
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

CHB Patients treated by Gastroenterologists/Hepatologists

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Treatment naïve and pre-treated CHB patients
subanalysis with migrant and non-migrant patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
After 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: After 2 years
After 2 years
Reasons for therapy non-persistence (therapy discontinuation) and low therapy adherence (qualitative questionnaire for causal assessment of non-persistence/non-adherence)
Time Frame: After 2 years
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
Time Frame: After 2 years
Hepatitis B virus (HBV), desoxyribonucleic acid (DNA), Alanine aminotransferase (ALT)
After 2 years
Frequency of Serious adverse drug reaction ((S)ADR)s and study discontinuations due to (S)ADRs
Time Frame: After 2 years
After 2 years
Number of participants with occuring resistances based on results from resistance tests
Time Frame: After 2 years
After 2 years
Assessment of Health Status (SF-12® Health Survey)
Time Frame: Assessment of Health Status (SF-12 Health Survey) at year 1
Assessment of Health Status (SF-12 Health Survey) at year 1
Assessment of Health Status (SF-12® Health Survey)
Time Frame: Assessment of Health Status (SF-12 Health Survey) at year 2
Assessment of Health Status (SF-12 Health Survey) at year 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

April 15, 2011

First Submitted That Met QC Criteria

May 18, 2011

First Posted (Estimate)

May 20, 2011

Study Record Updates

Last Update Posted (Estimate)

July 7, 2015

Last Update Submitted That Met QC Criteria

July 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI463-232

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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