Overview

This trial is active, not recruiting.

Condition hepatitis b
Treatments entecavir, entecavir, adefovir
Phase phase 4
Sponsor Nanfang Hospital of Southern Medical University
Collaborator JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
Start date December 2010
End date June 2014
Trial size 360 participants
Trial identifier NCT01341743, MOH-04

Summary

The purpose of this study is to evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir 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 efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
oral entecavir 1mg daily for 104 weeks
entecavir
patients will receive oral entecavir 1mg, daily for 104 weeks.
(Active Comparator)
oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
entecavir, adefovir
patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
(Active Comparator)
oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks
entecavir, adefovir
patients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks

Primary Outcomes

Measure
proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104
time frame: week 104

Secondary Outcomes

Measure
serum HBV DNA reduction from baseline at week 104
time frame: week 104
The proportion of subjects with ALT normalization at week 104
time frame: week104
The proportion of subjects with HBeAg loss and seroconversion at week 104
time frame: week104
The proportion of subject with HBsAg loss and seroconversion at week 104
time frame: week104
The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104
time frame: week104

Eligibility Criteria

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

Inclusion Criteria: - Male or female aged 18-65 years; - Capable of understanding and signing the informed consent. Willing to comply with the study requirements; - Serum HBsAg positive and ALT<10ULN at study screening; - Patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment; Exclusion Criteria: - History of viral breakthrough or genotypic resistance on previous therapy; - History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis; - Patient has a history of hepatocellular carcinoma(HCC) or findings suggestive of possible HCC; - Other protocol defined exclusion criteria.

Additional Information

Official title A Multi-center, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Generic Entecavir Monotherapy or in Combination With Adefovir for Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
Principal investigator JinLin Hou, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by Nanfang Hospital of Southern Medical University.