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

NCT00034359 | Completed Phase 2

• 1 other identifier: ACH443-003
• Study Type: interventional
• Target: 79
• Locations: 2 countries
• Sites: 3

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.

Conditions

Hepatitis B, Chronic

Keywords

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

Interventions

ACH-126,443 DRUG

Also known as: beta-L-Fd4C

Lamivudine DRUG

Placebo DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alexion Pharmaceuticals, Inc.: lead
• Achillion, a wholly owned subsidiary of Alexion: collaborator

Study Sites (3)

Clinical Trial Site

Sofia, Bulgaria

Location

Clinical Trial Site

Belgrade, Federal Republic of Yugoslavia

Location

Clinical Trial Site

Novi Sad, Federal Republic of Yugoslavia

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

dexelvucitabine; Lamivudine

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Zalcitabine; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Dideoxynucleosides

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2002
• First Posted: April 29, 2002
• Study Start: February 1, 2002
• Primary Completion: January 1, 2003
• Study Completion: January 1, 2003
• Last Updated: February 18, 2021

Record last verified: 2021-02

Locations

BU (1); FE (2)