A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection

This study has been terminated.

( Business Objectives Have Changed )

First Received: January 18, 2008 Last Updated: November 25, 2008 History of Changes

Sponsor:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00605384

Purpose

The purpose of this clinical research study is to find out whether a combination of entecavir plus tenofovir works better against Hepatitis B virus than adefovir added to continuing lamivudine therapy in patients whose Hepatitis B virus is resistant against lamivudine. The safety of this treatment will also be studied

Condition	Intervention	Phase
Chronic Hepatitis B	Drug: Entecavir + Tenofovir Drug: Adefovir + continuing Lamivudine	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Comparative Study of the Antiviral Efficacy and Safety of Entecavir Plus Tenofovir Versus Adefovir Added to Continuing Lamivudine in Adults With Lamivudine- Resistant Chronic Hepatitis B Virus Infection

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis B

Drug Information available for: Adefovir Lamivudine Entecavir Adefovir dipivoxil Tenofovir Tenofovir disoproxil Tenofovir Disoproxil Fumarate

U.S. FDA Resources

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

The proportion of subjects who achieve an HBV DNA level <50 IU/mL [ Time Frame: PCR at Week 48 of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

The proportion of subjects who achieve an HBV DNA level <50 IU/mL [ Time Frame: PCR at Week 96 of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	84
Study Start Date:	August 2008
Estimated Study Completion Date:	April 2012
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Entecavir + Tenofovir Tablets, Oral, ETV (Entecavir) = 1 mg + Tenofovir 300 mg, once daily, 100 weeks
2: Experimental	Drug: Adefovir + continuing Lamivudine Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic HBV infection
History of lamivudine treatment, and LVD resistance
Compensated liver function
HBV DNA ≥ 172,000 IU/mL
HBeAg-positive or HBeAg-negative
Documented LVDR substitutions
Men and women, ≥ 18 years of age

Exclusion Criteria:

Evidence of decompensated cirrhosis
Coinfection with HIV, HCV or HDV
Recent history of pancreatitis
Serum alpha fetoprotein > 100 ng/mL
Except lamivudine, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605384

Locations

United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Kaiser Permanente Medical Center
San Francisco, California, United States, 94118
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, New York
Local Institution
New York, New York, United States, 10025
Belgium
Local Institution
Leuven, Belgium, 3000
Local Institution
Bruxelles, Belgium, 1200
Germany
Local Institution
Berlin, Germany, 13353
Local Institution
Mainz, Germany, 55131
Local Institution
Bonn, Germany, 53105
Local Institution
Duesseldorf, Germany, 40237
Italy
Local Institution
Messina, Italy, 98124
Local Institution
San Giovanni Rotondo, Italy, 71013
Local Institution
Padova, Italy, 35128
Local Institution
Naples, Italy, 80135
Local Institution
Modena, Italy, 41100
Poland
Local Institution
Krakow, Poland, 31-531
Local Institution
Lublin, Poland, 20-089
Local Institution
Chorzow, Poland, 41-500
Turkey
Local Institution
Istanbul, Turkey, 34460
Local Institution
Istanbul, Turkey, 34722
Local Institution
Istanbul, Turkey, 34093
Local Institution
Istanbul, Turkey, 34360
Local Institution
Ankara, Turkey, 06620
Local Institution
Ankara, Turkey, 06010
Local Institution
Istanbul, Turkey, 34098
Local Institution
Izmir, Turkey, 35100
Local Institution
Sihhiye Ankara, Turkey, 06100
Local Institution
Trabzon, Turkey, 61080
Local Institution
Kocaeli, Turkey, 41380

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

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:	AI463-137
Study First Received:	January 18, 2008
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00605384 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Hepatitis, Chronic
Molecular Mechanisms of Pharmacological Action
Hepatitis, Viral, Human
Lamivudine
Infection
Hepadnaviridae Infections
Reverse Transcriptase Inhibitors
Entecavir
Anti-Retroviral Agents
Hepatitis B, Chronic
Therapeutic Uses
Hepatitis B

Tenofovir
Nucleic Acid Synthesis Inhibitors
Tenofovir disoproxil
Anti-HIV Agents
Enzyme Inhibitors
Antiviral Agents
Pharmacologic Actions
Virus Diseases
Hepatitis
Digestive System Diseases
Adefovir dipivoxil
DNA Virus Infections
Adefovir

ClinicalTrials.gov processed this record on February 08, 2010