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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01356901
First Posted: May 20, 2011
Last Update Posted: July 7, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bristol-Myers Squibb
  Purpose
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.

Condition
Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Persistence, Adherence and Clinical Effectiveness in Patients With Chronic Hepatitis B Viral Infection Treated With Entecavir in Real Life

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
  • 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 ]
  • 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)

  • Frequency of Serious adverse drug reaction ((S)ADR)s and study discontinuations due to (S)ADRs [ Time Frame: After 2 years ]
  • Number of participants with occuring resistances based on results from resistance tests [ Time Frame: 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) [ Time Frame: Assessment of Health Status (SF-12 Health Survey) at year 2 ]

Enrollment: 230
Study Start Date: January 2011
Study Completion Date: January 2015
Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Treatment naïve and pre-treated CHB patients
subanalysis with migrant and non-migrant patients

Detailed Description:
Sampling Method: Probability Sample (consecutive patient sampling)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
CHB Patients treated by Gastroenterologists/Hepatologists
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01356901


Locations
Germany
Local Institution
Herne, Germany, 44623
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01356901     History of Changes
Other Study ID Numbers: AI463-232
First Submitted: April 15, 2011
First Posted: May 20, 2011
Last Update Posted: July 7, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Anti-Infective Agents