Safety and Antiviral Study of ACH-126, 443 (Beta-L-Fd4C) in the Treatment of Adults With Chronic Hepatitis B Infection.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open-Label Treatment Protocol to Provide Continued ACH-126,443 to Subjects of Previous Achillion-Sponsored Phase 1 and 2 Studies in Chronic Hepatitis B Infection

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: ACH-126, 443 (beta-L-Fd4C)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 HIV negative 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) Exclusion Criteria HIV infection 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 Alcohol abuse 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ACH-126, 443 (beta-L-Fd4C)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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E-antigen positive, treatment naïve chronic HBV infected, lamivudine resistant chronic Hepatitis B, Achillion