Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00096785

Purpose

The purpose of this study is to evaluate antiviral activity and efficacy of entecavir compared to adefovir (a drug recently approved for the treatment of chronic Hepatitis b virus) in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.

Condition	Intervention	Phase
Hepatitis B Chronic Disease	Drug: entecavir Drug: adefovir	Phase III

MedlinePlus related topics: Coping with Chronic Illness Hepatitis Hepatitis B

Drug Information available for: Hepatitis B Vaccines Adefovir dipivoxil Adefovir Entecavir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Antiviral efficacy, as measured by the mean reduction in serum HBV DNA levels by PCR(log10 copies/mL) [ Time Frame: at Week 12 adjusted for baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Exploratory viral kinetics: HBV DNA by PCR<LOQ and normalization of ALT (<1xULM) [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
Response to Therapy: HBV Serology and HBV DNA [ Time Frame: at Weeks 48,60,76,92 & 96 ] [ Designated as safety issue: No ]
Relapse during 24-week post-dosing phase for those who achieve Response [ Time Frame: during 24-week post-dosing phase ] [ Designated as safety issue: No ]
Safety: Number and percentage of subjects with AEs,lab abnormalities and discontinuations due to AEs [ Time Frame: upon occurrence ] [ Designated as safety issue: Yes ]

Enrollment:	69
Study Start Date:	December 2004
Study Completion Date:	April 2008
Primary Completion Date:	January 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Active Comparator	Drug: entecavir Tablets, Oral, ETV = 0.5 mg, once daily, up to 96 weeks
A2: Active Comparator	Drug: adefovir Tablets, Oral, Adefovir, 10 mg, once daily, up to 96 weeks

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic hepatitis B treatment naive
Compensated liver disease

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00096785

Locations

United States, California
Local Institution
San Francisco, California, United States
Local Institution
San Diego, California, United States
Local Institution
Torrance, California, United States
United States, District of Columbia
Local Institution
Washington, District of Columbia, United States
United States, Florida
Local Institution
Miami, Florida, United States
Local Institution
North Miami Beach, Florida, United States
United States, New York
Local Institution
New York, New York, United States
United States, Pennsylvania
Local Institution
Philadelphia, Pennsylvania, United States
United States, Texas
Local Institution
Galveston, Texas, United States
Local Institution
Dallas, Texas, United States
Canada, Alberta
Local Institution
Edmonton, Alberta, Canada
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada
Canada, Ontario
Local Institution
Toronto, Ontario, Canada
Hong Kong
Local Institution
Chai Wan, Hong Kong
Local Institution
Tai Po, Hong Kong
Local Institution
Hong Kong, Hong Kong
Indonesia
Local Institution
Jakarta, Indonesia
Philippines
Local Institution
Cebu, Philippines
Local Institution
Manila, Philippines
Singapore
Local Institution
Singapore, Singapore
Taiwan
Local Institution
Taichung, Taiwan
Local Institution
Taipai, Taiwan

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Publications indexed to this study:

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.

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	AI463-079
Study First Received:	November 15, 2004
Last Updated:	October 9, 2008
ClinicalTrials.gov Identifier:	NCT00096785
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

chronic hepatitis B infection

Study placed in the following topic categories:

Liver Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis
Virus Diseases
Digestive System Diseases
Entecavir

Hepatitis B, Chronic
Hepatitis B
Chronic Disease
DNA Virus Infections
Adefovir dipivoxil
Adefovir

Additional relevant MeSH terms:

Anti-Infective Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Infection
Hepadnaviridae Infections
Antiviral Agents

Pharmacologic Actions
Reverse Transcriptase Inhibitors
Pathologic Processes
Anti-Retroviral Agents
Therapeutic Uses
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on January 16, 2009