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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01155427
Other study ID # AI463-186
Secondary ID
Status Completed
Phase N/A
First received June 29, 2010
Last updated June 30, 2010
Start date May 2009
Est. completion date April 2010

Study information

Verified date June 2010
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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


Description:

Systematic review of prospective clinical trials


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date April 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility 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:

Study Design

Observational Model: Cohort


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bristol-Myers Squibb

Outcome

Type Measure Description Time frame Safety issue
Primary Viral load No
Primary Histological improvement No
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