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
Information source: Bristol-Myers Squibb
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis B
Intervention: Entecavir + Tenofovir (Drug); Adefovir + continuing Lamivudine (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Bristol-Myers Squibb Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb
Overall contact:
For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com
Summary
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
Clinical Details
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
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The proportion of subjects who achieve an HBV DNA level <50 IU/mL
Secondary outcome: The proportion of subjects who achieve an HBV DNA level <50 IU/mL
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
For participation information at a USA site use a phone number below. For site information outside the USA please email:, Email: Clinical.Trials@bms.com
Local Institution, Leuven 3000, Belgium; Recruiting
Site 007
Local Institution, Bruxelles 1200, Belgium; Recruiting
Site 008
Local Institution, Berlin 13353, Germany; Recruiting
Site 001
Local Institution, Mainz 55131, Germany; Recruiting
Site 002
Local Institution, Bonn 53105, Germany; Recruiting
Site 003
Local Institution, Duesseldorf 40237, Germany; Recruiting
Site 010
Local Institution, Messina 98124, Italy; Not yet recruiting
Site 005
Local Institution, Naples 80135, Italy; Not yet recruiting
Site 006
Local Institution, Padova 35128, Italy; Not yet recruiting
Site 014
Local Institution, San Giovanni Rotondo 71013, Italy; Not yet recruiting
Site 015
Local Institution, Modena 41100, Italy; Not yet recruiting
Site 016
Local Institution, Istanbul 34460, Turkey; Not yet recruiting
Site 018
Local Institution, Istanbul 34722, Turkey; Not yet recruiting
Site 019
Local Institution, Istanbul 34093, Turkey; Not yet recruiting
Site 020
Local Institution, Istanbul 34360, Turkey; Not yet recruiting
Site 022
Local Institution, Kocaeli 41380, Turkey; Not yet recruiting
Site 025
Local Institution, Ankara 06010, Turkey; Not yet recruiting
Site 028
Local Institution, Istanbul 34098, Turkey; Not yet recruiting
Site 029
Local Institution, Izmir 35100, Turkey; Not yet recruiting
Site 031
Local Institution, Sihhiye Ankara 06100, Turkey; Not yet recruiting
Site 032
Local Institution, Trabzon 61080, Turkey; Not yet recruiting
Site 034
Cedars Sinai Medical Center, Los Angeles, California 90048, United States; Recruiting
Fred F. Poordad, Site 011
Kaiser Permanente Medical Center, San Francisco, California 94118, United States; Recruiting
Jeffrey Fessel, Site 026
Rush University Medical Center, Chicago, Illinois 60612, United States; Recruiting
Joseph Ahn, Site 027
Local Institution, New York, New York 10025, United States; Not yet recruiting
Site 033
Additional Information
BMS Clinical Trials Disclosure For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm
Starting date: August 2008
Ending date: April 2012
Last updated: October 20, 2008
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