At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 69 enrolled
Drug / intervention
entecavir +1 moredrug
Likely dose
Entecavir 0.5 mg orally once daily OR Adefovir 10 mg orally once daily (96 weeks)AI-extracted
Key inclusion· 2
- ✓Chronic hepatitis B infection with no prior nucleoside/nucleotide therapy
- ✓Compensated liver disease (no decompensation)
Key exclusion· 0
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Open-Label, Comparative Study to Evaluate Early Viral Load Reductions and Exploratory Viral Kinetics Following Administration of Entecavir or Adefovir in Nucleoside-Naive Adults With Chronic Hepatitis B Infection
In Brief
A Phase 3 clinical trial evaluating entecavir and adefovir for Hepatitis B and Chronic Disease. Completed, enrolled 69 participants across 24 sites in 8 countries.
Detailed Summary
The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B, Chronic Disease
CountriesCanada, Hong Kong, Indonesia, Philippines, Singapore, Taiwan, Thailand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 2004
Enrollment StartDec 2004
Primary CompletionJan 2006
Study CompletionApr 2008
TodayJul 2026
First PostedNov 16, 2004
Enrollment StartDec 1, 2004
Primary CompletionJan 1, 2006
Study CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 21.6 years ago
Interventions
entecavirdrug
Tablets, Oral, ETV 0.5 mg, once daily, up to 96 weeks
adefovirdrug
Tablets, Oral, ADV 10 mg, once daily, up to 96 weeks