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

Completed

• Conditions: Hepatitis B, Chronic

• Registration Number: NCT01356901
• Lead Sponsor: Bristol-Myers Squibb

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)

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-05-18
• Study First Posted: 2011-05-20
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-07-03
• Last Update Posted: 2015-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	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 Outcome Measures

Name	Time	Method
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	Hepatitis B virus (HBV), desoxyribonucleic acid (DNA), Alanine aminotransferase (ALT)
Frequency of Serious adverse drug reaction ((S)ADR)s and study discontinuations due to (S)ADRs	After 2 years

Trial Locations

Locations (1)

Local Institution; 🇩🇪 Herne, Germany