A Comparative Study of Chronic Hepatitis B Subjects Treated with Entecavir PlusTenofovir Combination Therapy vs Entecavir Monotherapy in Adults who are Treatment-Naïve to Nucleosides and Nucleotides: The BE-LOW Study.Revised Protocol 01, incorporating protocol amendment 02 (Version 2.0, Date 22-Jan-07). - The BE-LOW Study

Overview

No summary available.

Registry

who.int

Start Date

August 8, 2007

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\) Signed written informed consent
•2\) Nucleoside\- and nucleotide\-naïve subjects with chronic HBV infection (detectable
•HBsAg at screening and for at least 24 weeks prior to screening, or detectable
•HBsAg for \< 24 weeks and negative for IgM core antibody);
•3\) 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)
•4\) For HBeAg\-positive subjects, HBV DNA \>\= 172,000 IU/mL (approximately 1,000,000 copies/mL) by PCR at screening; OR For HBeAg\-negative subjects, HBV DNA \>\=17,200 IU/mL (approximately 100,000 copies/mL) by PCR at screening;

•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 dose of
•investigational product;
•2\) WOCBP using a prohibited contraceptive method. At this time there are no
•known contraindicated contraceptives to entecavir or tenofovir;
•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