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

NCT ID: NCT01155427

Last Updated: 2010-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-04-30

Brief Summary

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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

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Systematic review of prospective clinical trials

Conditions

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Hepatitis B, Chronic

Study Design

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Observational Model Type

COHORT

Study Groups

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entecavir

Patients initiating special antiviral treatments for CHB

No interventions assigned to this group

tenofovir

Patients initiating special antiviral treatments for CHB

No interventions assigned to this group

lamivudine

Patients initiating special antiviral treatments for CHB

No interventions assigned to this group

telbivudine

Patients initiating special antiviral treatments for CHB

No interventions assigned to this group

adefovir

Patients initiating special antiviral treatments for CHB

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Study Director

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Related Links

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http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

Other Identifiers

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AI463-186

Identifier Type: -

Identifier Source: org_study_id

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