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

A Double-Blind, Randomized Trial of Antiviral Activity and Safety of 12 Weeks Oral Treatment With ACH-126,443 (Beta-L-Fd4C) in Treatment-Naive HBV-Infected Adults

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00034359

Enrollment

Registered

2002-04-29

Start date

2002-02-28

Completion date

2003-01-31

Last updated

2021-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B, Chronic

Keywords

E-antigen Positive, Treatment-naive Chronic Hepatitis B, Achillion

Brief 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.

Detailed 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.

Interventions

DRUGACH-126,443

DRUGLamivudine

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Countries

Bulgaria, Federal Republic of Yugoslavia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026