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

Study Identifier:
ACH443-003
ClinicalTrials.gov Identifier:
NCT00034359
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Hepatitis
Study Drug
  • Drug: ACH-126,443
  • Drug: Lamivudine
  • Drug: Placebo
Date
Feb 2002 - Jan 2003
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion 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.
Sex
Female & Male
Age
18+ years

Study Details

Medical Condition
  • Hepatitis
Study Drug
  • Drug: ACH-126,443
  • Drug: Lamivudine
  • Drug: Placebo
Date
Feb 2002 - Jan 2003
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion 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.

Protocol 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.

Trial Locations

Location
Status
Location
Clinical Trial Site
Sofia, Bulgaria
Status
N/A
Location
Clinical Trial Site
Belgrade, Unmapped
Status
N/A
Location
Clinical Trial Site
Novi Sad, Unmapped
Status
N/A