Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation - Full Text View

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00065507

Purpose

This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation. The patients are treated for 96 weeks after the last subject is randomized.

Condition	Intervention	Phase
Hepatitis B	Drug: Entecavir Drug: Adefovir	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of the Efficacy and Safety of Entecavir Versus Adefovir in Subjects Chronically Infected With Hepatitis B Virus and Evidence of Hepatic Decompensation

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Adefovir Entecavir Adefovir dipivoxil

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Mean serum HBV DNA PCR adjusted for baseline [ Time Frame: at Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Discontinuation or dose reduction of study drug due to clinical AE or lab abnormality. Confirmed nephrotoxicity, defined as a < or equal to mg/dL increase in serum creatinine compared w/ baseline [ Time Frame: on 2 sequential measure ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	220
Study Start Date:	August 2003
Estimated Study Completion Date:	May 2013
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental	Drug: Entecavir Tablets, Oral, ETV = 1 mg once daily, 96 weeks from the time the last patient is randomized
A2: Active Comparator	Drug: Adefovir Tablets, Oral, 10 mg, once daily, 96 weeks from the time the last patient is randomized

Eligibility

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

Criteria

Inclusion

CP score >= 7
HBV viremia

Exclusion

ALT > 15 x ULN
HIV/HCV/HDV coinfection

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00065507

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Locations

United States, Connecticut
Yale University School Of Medicine
New Haven, Connecticut, United States, 06520
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, New York
Columbia University Medical Center (Cumc)
New York, New York, United States, 10032
Mount Sinai Medical Center
New York, New York, United States, 10029
Brazil
Local Institution
Sao Paulo, Brazil, 01246
Brazil, Rio Grande Do Sul
Local Institution
Porto Alegre - Rs, Rio Grande Do Sul, Brazil, 90035
Brazil, Sao Paulo
Local Institution
Sao Paulo - Sp, Sao Paulo, Brazil, 05403
Canada, Alberta
Local Institution
Calgary, Alberta, Canada, T2N 4N1
Canada, British Columbia
Local Institution
Vancouver, British Columbia, Canada, V5Z 1H2
Greece
Local Institution
Thessaloniki, Greece, 570 10
Local Institution
Thessaloniki, Greece, 54006
Local Institution
Athens, Greece, 15127
Local Institution
Athens, Greece, 11522
Local Institution
Athens, Greece, 11527
Hong Kong
Local Institution
Tai Po, Hong Kong, .
India
Local Institution
Lucknow, India, 226014
Local Institution
Kolkata, Bengal, India, 700020
Local Institution
New Delhi, India, 110002
India, Andhra Pradesh
Local Institution
Hyderabad, Andhra Pradesh, India, 500082
Indonesia
Local Institution
Jakarta, Indonesia, 10430
Italy
Local Institution
Milano, Italy, 20157
Local Institution
Parma, Italy, 43100
Philippines
Local Institution
Manila, Philippines, 1008
Poland
Local Institution
Lodz, Poland, 91-347
Local Institution
Bydgoszcz, Poland, 85-030
Local Institution
Chorzow, Poland, 41-500
Russian Federation
Local Institution
Moscow, Russian Federation, 117333
Singapore
Local Institution
Singapore, Singapore, 529889
Local Institution
Singapore, Singapore, 119074
South Africa, Western Cape
Local Institution
Observatory, Western Cape, South Africa, 7925
Local Institution
Goodwood, Western Cape, South Africa, 7460
Taiwan
Local Institution
Taoyuan, Taiwan, 333
Local Institution
Tianan, Taiwan, 704
Local Institution
Changhua, Taiwan, 500
Local Institution
Taichung, Taiwan, 404
Thailand
Local Institution
Bangkok, Thailand, 10400
Local Institution
Bangkok, Thailand, 10700
Local Institution
Hatyai, Thailand, 90110
Turkey
Local Institution
Izmir, Turkey, 35100

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

Additional Information:

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

Investigator Inquiry form This link exits the ClinicalTrials.gov site

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

No publications provided

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	AI463-048
Study First Received:	July 28, 2003
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00065507 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

hepatic decompensation

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Hepatitis, Viral, Human
Enzyme Inhibitors
Hepadnaviridae Infections
Antiviral Agents
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Hepatitis

Virus Diseases
Digestive System Diseases
Entecavir
Anti-Retroviral Agents
Therapeutic Uses
Hepatitis B
DNA Virus Infections
Adefovir dipivoxil
Adefovir
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on November 27, 2009