Clinical trial NCT00096785: Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection
Official title: Randomized, Open-Label, Comparative Study to Evaluate Early Viral Load Reductions and Exploratory Viral Kinetics Following Administration of Entecavir or Adefovir in Nucleoside-Naive Adults With Chronic Hepatitis B Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis B
Chronic Disease
Keywords: chronic hepatitis B infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2004-11-16
Enrollment: 69
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.


Eligibility criteria: Inclusion Criteria:

* Chronic hepatitis B treatment naive
* Compensated liver disease

Primary outcomes:
measure: Change From Baseline in Hepatitis B Virus DNA (HBV DNA) by Polymerase Chain Reaction (PCR) Assay at Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change From Baseline in HBV DNA by PCR Assay at Week 48
timeFrame: Baseline, Week 48
measure: Viral Load Undetectable (HBV DNA <300 Copies/mL)
timeFrame: Week 48
measure: Alanine Aminotransferase (ALT) Normalization
timeFrame: Week 48
measure: HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Efficacy in Blocking Virus Production and de Novo Infections
timeFrame: Week 12
measure: HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Viral Clearance Rate and Infected Cell Death Rate
timeFrame: Week 12
measure: HBV DNA Viral Kinetics Estimates of Exponential Decay Model - Half-Life of Free Virus
timeFrame: Week 12
measure: HBV DNA Viral Kinetics - Spline Model
timeFrame: Week 12
measure: Summary of Safety - Most Frequent (> 10%) Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Deaths
timeFrame: cumulative through the end of on-treatment observation as available at the time of the Week 48 dataset
measure: Summary of Safety - Laboratory Abnormalities Reported as Clinical AEs
timeFrame: Week 48
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Local Institution
state: California
city: San Francisco
country: United States
facility: Local Institution
state: California
city: Torrance
country: United States
facility: Local Institution
state: California
city: Miami
country: United States
facility: Local Institution
state: Florida
city: North Miami Beach
country: United States
facility: Local Institution
state: Florida
city: Baltimore
country: United States
facility: Local Institution
state: Maryland
city: New York
country: United States
facility: Local Insitution
state: New York
city: New York
country: United States
facility: Local Institution
state: New York
city: Philadelphia
country: United States
facility: Local Institution
state: Pennsylvania
city: Dallas
country: United States
facility: Local Institution
state: Texas
city: Galveston
country: United States
facility: Local Institution
state: Texas
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Chai Wan
country: Hong Kong
facility: Local Institution
city: Pokfulham
country: Hong Kong
facility: Local Institution
city: Tai Po
country: Hong Kong
facility: Local Institution
city: Jakarta
country: Indonesia
facility: Local Institution
city: Cebu
country: Philippines
facility: Local Institution
city: Manila
country: Philippines
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taoyan
country: Taiwan
facility: Local Institution
city: Bankok
country: Thailand
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Leung N, Peng CY, Hann HW, Sollano J, Lao-Tan J, Hsu CW, Lesmana L, Yuen MF, Jeffers L, Sherman M, Min A, Mencarini K, Diva U, Cross A, Wilber R, Lopez-Talavera J. Early hepatitis B virus DNA reduction in hepatitis B e antigen-positive patients with chronic hepatitis B: A randomized international study of entecavir versus adefovir. Hepatology. 2009 Jan;49(1):72-9. doi: 10.1002/hep.22658.