At a glance
ClinicalIndex Comparison Record- ✓Documented chronic HBV infection with HBsAg positive for at least 6 months
- ✓Age 18-69 years old
- ✓HBeAg-negative status with positive HBeAb at screening
- ✓High viral load: HBV DNA >100,000 copies/mL at screening
- ✕Decompensated liver disease: conjugated bilirubin >1.5× ULN, PT >1.5× ULN, platelets <75,000/mL, albumin <3.0 g/dL, or history of ascites/jaundice/encephalopathy/variceal bleeding
- ✕Any nucleoside, nucleotide, or interferon therapy within 6 months prior to pre-treatment biopsy
- ✕Evidence of hepatocellular carcinoma
- ✕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 Presumed Pre-Core Mutant Chronic Hepatitis B
In Brief
A Phase 3 clinical trial evaluating TDF, ADV, and 3 other interventions for Chronic Hepatitis B. Completed, enrolled 382 participants across 80 sites in 15 countries.
Detailed Summary
This 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 pre-core mutant 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