Status:

COMPLETED

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

Lead Sponsor:

Bristol-Myers Squibb

Conditions:

Hepatitis B, Chronic

Eligibility:

All Genders

16+ years

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.

Detailed Description

Systematic review of prospective clinical trials

Eligibility Criteria

Inclusion

  • 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

  • N/A

Key Trial Info

Start Date :

May 1 2009

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

April 1 2010

Estimated Enrollment :

100 Patients enrolled

Trial Details

Trial ID

NCT01155427

Start Date

May 1 2009

End Date

April 1 2010

Last Update

July 1 2010

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