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Systematic Review of Antiretroviral Treatments for Chronic Hepatitis B (CHB)

This study has been completed.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: June 29, 2010
Last updated: June 30, 2010
Last verified: June 2010
The purpose of this study is to support the clinical value of entecavir by assessing the relationship between viral load and histological improvement.

Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: A Systematic Review of Literature on Common Antiretroviral Treatments Against Hepatitis B Virus (HBV)

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Viral load
  • Histological improvement

Enrollment: 100
Study Start Date: May 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Patients initiating special antiviral treatments for CHB
Patients initiating special antiviral treatments for CHB
Patients initiating special antiviral treatments for CHB
Patients initiating special antiviral treatments for CHB
Patients initiating special antiviral treatments for CHB

Detailed Description:
Systematic review of prospective clinical trials

Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clinical trial enrollees

Inclusion Criteria:

  • Patients with CHB diagnosis and no co-infection with Hep A, Hep C, Hep D, or HIV
  • Age 16 years or older
  • No post-transplant patients
  • RCT, non-randomized trials, prospective cohort studies, prospectively analyses case series published since 2003
  • At least one arm of trial must include monotherapy with entecavir, lamivudine, tenofovir, adefovir, or telbivudine
  • Study arms must include at least 10 patients
  • Follow-up of at least 48 weeks
  • Published results available in English language

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT01155427

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

Additional Information:
Responsible Party: Bristol-Myers Squibb, Study Director Identifier: NCT01155427     History of Changes
Other Study ID Numbers: AI463-186
Study First Received: June 29, 2010
Last Updated: June 30, 2010

Additional relevant MeSH terms:
Hepatitis A
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
Hepatitis, Chronic processed this record on May 25, 2017