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:
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