A Randomized Trial of Switching Antiviral Therapy from Lamivudine to Telbivudine (LdT) vs. Continued Lamivudine Treatment in Adults with Chronic Hepatitis B

Idenix Pharmaceuticals, Inc.0 sites230 target enrollmentMarch 22, 2005

Overview

No summary available.

Registry

who.int

Start Date

March 22, 2005

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients must meet all of the following inclusion criteria:
•Male or female, 18 to 70 years of age
•Documented compensated chronic hepatitis B defined by all of the following:
•Clinical history compatible with compensated chronic hepatitis B
•Detectable serum HBsAg at the Screening visit
•HBeAg seropositive or seronegative
•History of evidence of chronic liver inflammation, documented by previous history
•of elevated serum ALT and/or AST levels (at least two elevated ALT or AST values
•spanning six months or more, documented in available records), and/or chronic
•liver inflammation documented on previous liver biopsy with available pathology

•Patient is pregnant or breastfeeding.
•Patient is of childbearing potential (men and women) and unwilling to use a barrier
•method of contraception. It is required that a barrier method of contraception be
•used (i.e. condom with spermicide or diaphragm with spermicide) by patients of
•childbearing potential (men and women) regardless of whether a hormonal agent
•also is used as a method of contraception.
•Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV), HIV\-1 or
•HIV\-2\. Patients will be tested for antibodies to HCV, HIV, and HDV in the
•Screening assessments performed at the central laboratory.
•Patient previously received antiviral treatment for hepatitis B other than lamivudine