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

June 30, 2010 updated by: Bristol-Myers Squibb

A Systematic Review of Literature on Common Antiretroviral Treatments Against Hepatitis B Virus (HBV)

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

Study Overview

Status

Completed

Conditions

Detailed Description

Systematic review of prospective clinical trials

Study Type

Observational

Enrollment (Actual)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinical trial enrollees

Description

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:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Viral load
Histological improvement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

June 29, 2010

First Submitted That Met QC Criteria

June 30, 2010

First Posted (Estimate)

July 1, 2010

Study Record Updates

Last Update Posted (Estimate)

July 1, 2010

Last Update Submitted That Met QC Criteria

June 30, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AI463-186

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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