At a glance
ClinicalIndex Comparison Record- ✓HBeAg-positive chronic HBV infection with HBsAg positive for >6 months
- ✓HBeAg positive at screening
- ✓ALT >2× ULN and ≤10× ULN
- ✓Serum HBV DNA >1 million copies/mL at screening
- ✕Decompensated liver disease: conjugated bilirubin >1.5× ULN, PT >1.5× ULN, platelets <75,000/mL, serum albumin <3.0 g/dL, or prior hepatic decompensation
- ✕Prior nucleoside, nucleotide, or interferon therapy within 6 months of pre-treatment biopsy
- ✕α-fetoprotein >50 ng/mL (evidence of HCC)
- ✕Coinfection with HCV, HIV, or HDV
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF Versus Adefovir Dipivoxil for the Treatment of HBeAg Positive Chronic Hepatitis B
In Brief
A Phase 3 clinical trial evaluating TDF, ADV, and 3 other interventions for Chronic Hepatitis B. Completed, enrolled 266 participants across 87 sites in 15 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
300 mg tablet administered orally once daily
10 mg tablet administered orally once daily
Tablet administered orally once daily
Tablet administered orally once daily
200/300 mg fixed-dose combination (FDC) tablet administered orally once daily