Comparison of the Efficacy and Safety of Entecavir Versus Adefovir in Subjects Chronically Infected With Hepatitis B Virus and Evidence of Hepatic Decompensation


Phase 3
16 Years
N/A
Not Enrolling
Both
Hepatitis B

Thank you

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