Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

Phase 4

• Conditions: Hepatitis B
• Interventions: Drug: Entecavir, Adefovir; Drug: Entecavir

• Registration Number: NCT01341743
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-02-16
• Study First Submitted QC: 2011-04-25
• Study First Posted: 2011-04-26
• Status Verified: 2013-09
• Last Update Submitted: 2013-10-28
• Last Update Posted: 2013-10-30
• Primary Completion: 2014-06
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B	Entecavir, Adefovir	oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
C	Entecavir, Adefovir	oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks
A	Entecavir	oral entecavir 1mg daily for 104 weeks

Primary Outcome Measures

Name	Time	Method
proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104	week 104

Secondary Outcome Measures

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

Trial Locations

Locations (16)

Shanghai Ruijin Hospital; 🇨🇳 ShangHai, Shanghai, China

First Hospital .Jilin Unniversity; 🇨🇳 ChangChun, Jilin, China

Changhai Hospital affiliated to Second Military Medical University; 🇨🇳 ShangHai, Shanghai, China

Beijing Ditan Hospita; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital Attached to the Capital Medical University; 🇨🇳 Beijing, Beijing, China

Department of infectious disease, First Hospital of Peking University; 🇨🇳 BeiJing, Beijing, China

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 FuZhou, Fujian, China

The First People's Hospital of Foshan; 🇨🇳 FoShan, Guangdong, China

People'S Hospital Under Beijnig University; 🇨🇳 Beijing, Beijing, China

Department of infectious disease, Nanfang Hospital; 🇨🇳 GuangZhou, Guangdong, China

GuangDong Provincial People's hospital; 🇨🇳 GuangZhou, Guangdong, China

First Affiliated Hospital of Guangxi Medical University; 🇨🇳 NanNing, Guangxi, China

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Xiangya Hospital Central-South Univrsity; 🇨🇳 ChangSha, Hunan, China

ShengJing Hospital of China Medical University; 🇨🇳 ShenYang, Liaoning, China

Huashan Hospital，Fudan University; 🇨🇳 ShangHai, Shanghai, China