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

History of Changes

Tracking Information

First Received Date ^ICMJE

June 29, 2010

Last Updated Date

June 30, 2010

Start Date ^ICMJE

May 2009

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Viral load [ Designated as safety issue: No ]
Histological improvement [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01155427 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Clinical trial enrollees

Condition ^ICMJE

Hepatitis B, Chronic

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

100

Completion Date

April 2010

Primary Completion Date

April 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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:

Gender

Both

Ages

16 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01155427

Other Study ID Numbers ^ICMJE

AI463-186

Has Data Monitoring Committee

Responsible Party

Bristol-Myers Squibb, Study Director

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

June 2010

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

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