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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 UniversityBaltimore, Maryland  21205
Mount Sinai Medical CenterNew York, New York  10029
Baylor University Medical CenterDallas, Texas  75246
McGuire DVAMCRichmond, Virginia  23249
California Pacific Medical CenterSan Francisco, California  94115
Yale University School Of MedicineNew Haven, Connecticut  06520
University of Miami School of MedicineMiami, Florida  33136
Research And Education, Inc.San Diego, California  92115
Pediatric GasteroenterologyAtlanta, Georgia  30342
Hawaii Medical Center EastHonolulu, Hawaii  96817
Indiana University Med CenterIndianapolis, Indiana  46202
The Cht Liver Research CenterLouisville, Kentucky  40292
Henry Ford Health System IrbDetroit, Michigan  48202
Columbia Presbyterian Medical Center (Cpmc)New York, New York  10032
Integris Baptist Medical CenterOklahoma City, Oklahoma  73112
Ut Southwestern Medical CenterDallas, Texas  75390