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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01155427
• Other study ID #: AI463-186
• 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

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

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

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
•   Investigator Inquiry form