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

NCT ID: NCT00034359

Last Updated: 2021-02-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2003-01-31

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.

Conditions

Hepatitis B, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

ACH-126,443

Intervention Type: DRUG

Lamivudine

Intervention Type: DRUG

Placebo

Intervention Type: DRUG

Other Intervention Names

beta-L-Fd4C

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Achillion, a wholly owned subsidiary of Alexion

INDUSTRY

Sponsor Role: collaborator

Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinical Trial Site

Sofia, , Bulgaria

Clinical Trial Site

Belgrade, , Federal Republic of Yugoslavia

Clinical Trial Site

Novi Sad, , Federal Republic of Yugoslavia

Countries

Bulgaria; Federal Republic of Yugoslavia

Other Identifiers

ACH443-003

Identifier Type: -

Identifier Source: org_study_id