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

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ClinicalTrials.gov Identifier: NCT01155427
Recruitment Status : Completed
First Posted : July 1, 2010
Last Update Posted : July 1, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to support the clinical value of entecavir by assessing the relationship between viral load and histological improvement.

Condition or disease
Hepatitis B, Chronic

Detailed Description:
Systematic review of prospective clinical trials

Study Design

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Official Title: A Systematic Review of Literature on Common Antiretroviral Treatments Against Hepatitis B Virus (HBV)
Study Start Date : May 2009
Primary Completion Date : April 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
entecavir
Patients initiating special antiviral treatments for CHB
tenofovir
Patients initiating special antiviral treatments for CHB
lamivudine
Patients initiating special antiviral treatments for CHB
telbivudine
Patients initiating special antiviral treatments for CHB
adefovir
Patients initiating special antiviral treatments for CHB


Outcome Measures

Primary Outcome Measures :
  1. Viral load
  2. Histological improvement

Eligibility Criteria

Information from the National Library of Medicine

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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
Criteria

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

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): NCT01155427


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

Additional Information:
Responsible Party: Bristol-Myers Squibb, Study Director
ClinicalTrials.gov Identifier: NCT01155427     History of Changes
Other Study ID Numbers: AI463-186
First Posted: July 1, 2010    Key Record Dates
Last Update Posted: July 1, 2010
Last Verified: June 2010

Additional relevant MeSH terms:
Hepatitis
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