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About
The primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (TDF) versus adefovir dipivoxil (ADV) for the treatment of HBeAg-positive chronic hepatitis B. Participants will receive TDF or ADV for 48 weeks (double-blind). After 48 weeks, eligible participants switched to open-label TDF for up to 480 weeks.
Enrollment
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Inclusion and exclusion criteria
Key Inclusion Criteria:
A patient must meet all of the following inclusion criteria to be eligible for participation in this study:
Chronic hepatitis B virus (HBV) infection, defined as positive serum hepatitis B s-antigen (HBsAg) for more than 6 months
18 through 69 years of age, inclusive
Active hepatitis B e-antigen (HBeAg) positive chronic HBV infection, with all of the following:
Knodell necroinflammatory score ≥ 3 and a Knodell fibrosis score < 4; however, up to 96 patients with cirrhosis, ie, a Knodell fibrosis score equal to 4, will be eligible for enrollment
Negative serum β-human chorionic gonadotropin (hCG)
Nucleotide naïve, ie, no prior nucleotide (TDF or ADV) therapy for > 12 weeks
Nucleoside naïve, ie, no prior nucleoside (any nucleoside) therapy for > 12 weeks
Willing and able to provide written informed consent
Liver biopsy performed within 6 months of baseline and has readable biopsy slides or agrees to have a biopsy performed prior to baseline
Key Exclusion Criteria:
A patient who meets any of the following exclusion criteria is not to be enrolled in this study:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Primary purpose
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Interventional model
Masking
266 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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