Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment Naive Adults With Chronic Hepatitis B Virus Infection
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The purpose of this study is to determine the safety and anti-HBV activity of ACH-126, 443 (beta-L-Fd4C) in comparison to lamivudine or placebo in treatment naive adults with chronic Hepatitis B infection.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Adults >= 18 years of age
Chronic HBV infection, known to be HbsAg positive >= 6 months
Plasma HBV DNA level >= 100,000 copies/mL
Basic hematologic and chemistry parameters within acceptable limits (defined in protocol
No need for excluded medications
Subjects of reproductive capability must utilize two approved forms of birth control, one of which must be barrier protection.
Hepatitis C co-infection
Concurrent systemic antiviral treatment
Previous antiviral treatment for HBV infection within 6 months prior to randomization or treatment with 3TC for more than 6 months at any time in the past
Previous therapy with agents with significant systemic myelosuppressive or cytotoxic potential within 3 months of study start or the expected need for such therapy at study start
Pregnancy or breast-feeding
Inability to tolerate oral medication
AST>7.0 times the upper limit of normal
ALT>7.0 times the upper limit of normal
Any clinical condition or prior therapy that, in the Investigators opinion, would make the subject unsuitable for the study or unable to comply with the dosing requirements