Comparison of the Efficacy and Safety of Entecavir Versus Adefovir in Subjects Chronically Infected With Hepatitis B Virus and Evidence of Hepatic Decompensation
16 Years
N/A
Both
Hepatitis B
Trial Information
Comparison of the Efficacy and Safety of Entecavir Versus Adefovir in Subjects Chronically Infected With Hepatitis B Virus and Evidence of Hepatic Decompensation
Inclusion Criteria
Inclusion
- Child-Pugh (CP) score >= 7
- Hepatitis B virus (HBV) viremia
Exclusion
- Alanine aminotransferase (ALT) > 15 x upper limit of normal (ULN)
- Human immunodeficiency virus (HIV)/hepatitis C virus (HCV)/hepatitis D virus (HDV)
coinfection
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Change From Baseline in Hepatitis B Virus (HBV) DNA by Polymerase Chain Reaction (PCR) at Week 24
Outcome Description:
Mean reduction in serum HBV DNA determined by PCR assay (log10 copies/mL) at Week 24 adjusted for baseline HBV DNA and lamivudine resistance (LVDr) status, based on linear regression analysis.
Outcome Time Frame:
Baseline, Week 24
Safety Issue:
No
Principal Investigator
Bristol-Myers Squibb
Investigator Role:
Study Director
Investigator Affiliation:
Bristol-Myers Squibb
Authority:
United States: Food and Drug Administration
Study ID:
AI463-048
NCT ID:
NCT00065507
Start Date:
August 2003
Completion Date:
May 2013
Related Keywords:
- Hepatitis B
- hepatic decompensation
- Hepatitis
- Hepatitis A
- Hepatitis B
- Hepatitis, Chronic
- Hepatitis B, Chronic
Name | Location |
|---|---|
| Johns Hopkins University | Baltimore, Maryland 21205 |
| Mount Sinai Medical Center | New York, New York 10029 |
| Baylor University Medical Center | Dallas, Texas 75246 |
| McGuire DVAMC | Richmond, Virginia 23249 |
| California Pacific Medical Center | San Francisco, California 94115 |
| Yale University School Of Medicine | New Haven, Connecticut 06520 |
| University of Miami School of Medicine | Miami, Florida 33136 |
| Research And Education, Inc. | San Diego, California 92115 |
| Pediatric Gasteroenterology | Atlanta, Georgia 30342 |
| Hawaii Medical Center East | Honolulu, Hawaii 96817 |
| Indiana University Med Center | Indianapolis, Indiana 46202 |
| The Cht Liver Research Center | Louisville, Kentucky 40292 |
| Henry Ford Health System Irb | Detroit, Michigan 48202 |
| Columbia Presbyterian Medical Center (Cpmc) | New York, New York 10032 |
| Integris Baptist Medical Center | Oklahoma City, Oklahoma 73112 |
| Ut Southwestern Medical Center | Dallas, Texas 75390 |
