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

• Status: Completed
• Trial end date: 2003-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study was to determine the safety and anti-hepatitis B virus (-HBV) activity of ACH-126,443 in comparison to lamivudine or placebo in treatment-naive adults with chronic hepatitis B infection.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Achillion Pharmaceuticals; Alexion Pharmaceuticals
• Collaborator: Achillion, a wholly owned subsidiary of Alexion
• Treatments: Antiviral Agents; Lamivudine

Criteria

Inclusion Criteria:

• Chronic hepatitis B virus (HBV) infection, known to be hepatitis B surface antigen positive ≥ 6 months.

• Plasma HBV deoxyribonucleic acid level ≥ 100,000 copies/milliliter.

• Hepatitis B e-antigen positive.

• Human immunodeficiency virus negative.

• Basic hematologic and chemistry parameters within acceptable limits (defined in protocol).

• No need for excluded medications.

• Participants of reproductive capability must have utilized 2 approved forms of birth control, one of which must have been barrier protection.

Exclusion Criteria:

• Human immunodeficiency virus infection.

• Hepatitis C co-infection.

• Concurrent systemic antiviral treatment.

• Previous antiviral treatment for HBV infection within 6 months prior to randomization or treatment with lamivudine 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.

• Alcohol abuse.

• Pregnancy or breast-feeding.

• Inability to tolerate oral medication.

• Aspartate aminotransferase > 7.0 times the upper limit of normal.

• Alanine aminotransferase > 7.0 times the upper limit of normal.

• Any clinical condition or prior therapy that, in the Investigators opinion, would make the participant unsuitable for the study or unable to comply with the dosing requirements.

• Use of any investigational drug.