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

Alexion Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Hepatitis B, Chronic

Treatments

Drug: ACH-126,443

Drug: Lamivudine

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00034359

ACH443-003

Details and patient eligibility

About

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.

Full description

Evaluation of the safety and antiviral activity of 3 dose levels of ACH-126,443 versus lamivudine and placebo over 12 weeks of treatment in the population is described.

Enrollment

79 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.