Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With C… (NCT00034359) | Clinical Trial Compass
CompletedPhase 2
Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus Infection
Bulgaria, Federal Republic of Yugoslavia79 participantsStarted 2002-02
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.