A Comparative Study of Entecavir vs Adefovir Plus Lamivudine vs CombinationEntecavir plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Subjects: TheDEFINE StudyRevised Protocol 02, incorporating protocol amendment 02 (Version 2.0, date 23-Jan-2007), protocol amendment 03 (Version 4.0, date 07-Nov-2007) and Administrative Letter 01. - The DEFINE Study

Overview

No summary available.

Registry

who.int

Start Date

April 30, 2008

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\) Signed written informed consent;
•2\) Subjects must have a history of previous lamivudine treatment at screening, and must have LVD resistance substitutions at reverse transcriptase rtM204I/V;
•3\) Subjects must be nucleoside\- and nucleotide\-naïve, except for lamivudine, and
•have chronic HBV infection (detectable HBsAg at screening and at least 24 weeks
•prior to screening, or detectable HBsAg for \< 24 weeks and negative for IgM core
•4\) Subjects must have compensated liver function and must meet ALL of the
•following criteria:
•International Normalization Ratio (INR) \= 1\.5
•Serum albumin \= 3 g/dL (\= 30 g/L)
•Serum total bilirubin \= 2\.5 mg/dL (\= 42\.75 µmol/L)

•1\) WOCBP who are unwilling or unable to use an acceptable method to avoid
•pregnancy for the entire study period and for up to 6 weeks after the last does of
•investigational product;
•2\) WOCBP using a prohibited contraceptive method. At this time there are no
•known contraindicated contraceptives to entecavir or adefovir or lamivudine;
•3\) Women who are pregnant or breastfeeding;
•4\) Women with a positive pregnancy test on enrollment or prior to investigational
•product administration;
•5\) Sexually active fertile men not using effective birth control if their partners are
•6\) Evidence of decompensated cirrhosis including but not limited to: variceal