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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01356901
First received: April 15, 2011
Last updated: August 14, 2014
Last verified: August 2014
  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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Number of participants with occuring resistances based on results from resistance tests [ Time Frame: After 2 years ] [ Designated as safety issue: No ]
  • Assessment of Health Status (SF-12® Health Survey) [ Time Frame: Assessment of Health Status (SF-12 Health Survey) at year 1 ] [ Designated as safety issue: No ]
  • Assessment of Health Status (SF-12® Health Survey) [ Time Frame: Assessment of Health Status (SF-12 Health Survey) at year 2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01356901

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01356901     History of Changes
Other Study ID Numbers: AI463-232
Study First Received: April 15, 2011
Last Updated: August 14, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Chronic
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on October 20, 2014