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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
  Purpose

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


Condition
Hepatitis B, Chronic

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: A Systematic Review of Literature on Common Antiretroviral Treatments Against Hepatitis B Virus (HBV)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Viral load [ Designated as safety issue: No ]
  • Histological improvement [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: May 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

Systematic review of prospective clinical trials

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Clinical trial enrollees

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155427

Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

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

No publications provided

Responsible Party: Bristol-Myers Squibb, Study Director
ClinicalTrials.gov Identifier: NCT01155427     History of Changes
Other Study ID Numbers: AI463-186
Study First Received: June 29, 2010
Last Updated: June 30, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on May 22, 2013