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

Stopped early · Phase 3

Conditions studied: Chronic Hepatitis B

In brief

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

Key facts

Study ID

NCT00605384

Run by

Bristol-Myers Squibb

People needed

4

Starts

2008-08-01

Expected to finish

2009-02-01

Last updated by the study team

2010-11-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic HBV infection
• History of lamivudine (LVD) treatment, and lamivudine resistance (LVDr), receiving LVD at screening visit
• Compensated liver function
• HBV DNA ≥ 172,000 IU/mL
• Hepatitis B e-antigen (HBeAg)-positive or HBeAg-negative

You may not qualify if…

• Evidence of decompensated cirrhosis
• Coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis D virus (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

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States
• Kaiser Permanente Medical Center — San Francisco, California, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Local Institution — New York, New York, United States
• Local Institution — Brussels, Belgium
• Local Institution — Leuven, Belgium
• Local Institution — Berlin, Germany
• Local Institution — Bonn, Germany
• Local Institution — Düsseldorf, Germany
• Local Institution — Mainz, Germany
• Local Institution — Messina, Italy
• Local Institution — Modena, Italy
• Local Institution — Naples, Italy
• Local Institution — Padova, Italy
• Local Institution — San Giovanni Rotondo, Italy
• Local Institution — Chorzów, Poland
• Local Institution — Krakow, Poland
• Local Institution — Lublin, Poland
• Local Institution — Ankara, Turkey (Türkiye)
• Local Institution — Ankara, Turkey (Türkiye)
• Local Institution — Istanbul, Turkey (Türkiye)
• Local Institution — Istanbul, Turkey (Türkiye)
• Local Institution — Istanbul, Turkey (Türkiye)
• Local Institution — Istanbul, Turkey (Türkiye)
• Local Institution — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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