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

Hepatitis B, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00034359
• Other study ID #: ACH443-003
• Status: Completed
• Phase: Phase 2
• Start date: February 2002
• Est. completion date: January 2003

Study information

• Verified date: February 2021
• Source: Alexion Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: January 2003
• Est. primary completion date: January 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• ACH-126,443

• Lamivudine

• Placebo

Locations

Country	Name	City	State
Bulgaria	Clinical Trial Site	Sofia
Former Yugoslavia	Clinical Trial Site	Belgrade
Former Yugoslavia	Clinical Trial Site	Novi Sad

Sponsors (2)

Lead Sponsor	Collaborator
Alexion Pharmaceuticals	Achillion, a wholly owned subsidiary of Alexion

Countries where clinical trial is conducted

Bulgaria,  Former Yugoslavia,