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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01356901
• Other study ID #: AI463-232
• Status: Completed
• Phase: N/A
• First received: April 15, 2011
• Last updated: July 3, 2015
• Start date: January 2011
• Est. completion date: January 2015

Study information

• Verified date: June 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Description:

Sampling Method: Probability Sample (consecutive patient sampling)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Locations

Country	Name	City	State
Germany	Local Institution	Herne

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	No
Secondary	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	No
Secondary	Reasons for therapy non-persistence (therapy discontinuation) and low therapy adherence (qualitative questionnaire for causal assessment of non-persistence/non-adherence)		After 2 years	No
Secondary	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	Hepatitis B virus (HBV), desoxyribonucleic acid (DNA), Alanine aminotransferase (ALT)	After 2 years	No
Secondary	Frequency of Serious adverse drug reaction ((S)ADR)s and study discontinuations due to (S)ADRs		After 2 years	Yes
Secondary	Number of participants with occuring resistances based on results from resistance tests		After 2 years	No
Secondary	Assessment of Health Status (SF-12® Health Survey)		Assessment of Health Status (SF-12 Health Survey) at year 1	No
Secondary	Assessment of Health Status (SF-12® Health Survey)		Assessment of Health Status (SF-12 Health Survey) at year 2	No

External Links

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