Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With Chronic Hepatitis B Infection.
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ClinicalTrials.gov Identifier: NCT00037622
(Safety concerns from other studies.)
The purpose of this study is to determine the safety and antiviral HBV activity of ACH-126,443 (beta-L-Fd4C) in the treatment of Subjects of Previous Achillion-Sponsored Phase 1 and 2 Studies in Chronic Hepatitis B Infection.
Condition or disease
Chronic Hepatitis B
Drug: ACH-126, 443 (beta-L-Fd4C)
Evaluation of safety and antiviral activity of the 5mg dose of ACH-126,443 for up to three months of treatment in the population described.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Participants in previous Phase 1 or 2 trials of ACH-126,443 who met entry criteria for previous studies.
Adults ? 18 years of age
Chronic HBV infection, known to be HbsAg positive ? 6 months
Plasma HBV DNA level ? 100,000 copies/mL prior to initiation of ACH-126,443 in an earlier study
Plasma HBV DNA level that in the medical judgment of the investigator, warrant's antiviral treatment
Basic hematologic and chemistry parameters within acceptable limits (defined in protocol)
No need for excluded medications
Subjects of reproductive capability must either practice abstinence or utilize two approved forms of birth control, one of which must be barrier protection (condom with spermicidal, diaphragm with spermicidal)
Active Hepatitis C co-infection
Concurrent systemic antiviral treatment
Treatment for HBV infection with lamivudine (3TC) for longer than three (3) months since participation in previous trial of ACH-126,443
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>10.0 times the upper limit of normal
ALT>10.0 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
Use of investigational drug not approved by Medical Monitor