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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01155427
First received: June 29, 2010
Last updated: June 30, 2010
Last verified: June 2010

June 29, 2010
June 30, 2010
May 2009
April 2010   (final data collection date for primary outcome measure)
  • Viral load [ Designated as safety issue: No ]
  • Histological improvement [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01155427 on ClinicalTrials.gov Archive Site
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Systematic Review of Antiretroviral Treatments for Chronic Hepatitis B (CHB)
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.

Systematic review of prospective clinical trials

Observational
Observational Model: Cohort
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Non-Probability Sample

Clinical trial enrollees

Hepatitis B, Chronic
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  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT01155427
AI463-186
No
Bristol-Myers Squibb, Study Director
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP