Overview

This trial is active, not recruiting.

Conditions chronic hepatitis b, inadequate response, nucleos(t)ide analogues treatment
Treatment entecavir, adefovir
Phase phase 4
Sponsor Nanfang Hospital of Southern Medical University
Collaborator Major Science and Technology Special Project of China Eleventh Five-year
Start date March 2013
End date June 2016
Trial size 360 participants
Trial identifier NCT01829685, MOH-06

Summary

The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
oral entecavir 1mg daily and adefovir 10mg daily for 144 weeks
entecavir, adefovir
(Active Comparator)
oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
entecavir, adefovir

Primary Outcomes

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

Secondary Outcomes

Measure
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group.
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 104-week Dragon 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 Therapy for Patients Previously Treated in Dragon Study
Principal investigator Jinlin Hou, MD
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.