Overview

This trial is active, not recruiting.

Condition chronic hepatitis b
Treatment oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
Phase phase 4
Sponsor Nanfang Hospital of Southern Medical University
Collaborator Major Science and Technology Special Project of China 12th Five-year
Start date March 2013
End date June 2016
Trial size 600 participants
Trial identifier NCT01834508, MOH-07

Summary

The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks

Primary Outcomes

Measure
Percentages of patients achieving HBV DNA< 300copies/mL at week 144
time frame: Week 144

Secondary Outcomes

Measure
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96
time frame: Week 48 & 96
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144
time frame: Week 48 & 96 &144
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.
time frame: Week 48 & 96 & 144
Percentage of patients with ALT normalization at week 48/96/144
time frame: Week 48 & 96 & 144

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Subjects who completed the EXPLORE or EXCEL studies, or subjects with hepatitis flare after treatment withdrawal in EFFORT study. - Subjects who are willing to participate the extension study. Exclusion Criteria: - Subjects who could not compliance with the protocol judged by investigators

Additional Information

Official title A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Plus Adefovir Combination Treatment for Patients Previously Treated in EXPLORE, EXCEL and EFFORT Ex Study
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by Nanfang Hospital of Southern Medical University.