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

Condition(s) targeted: Hepatitis B

Intervention: Entecavir (Drug); Entecavir, Adefovir (Drug); Entecavir, Adefovir (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Nanfang Hospital of Southern Medical University

Official(s) and/or principal investigator(s):
JinLin Hou, MD, Principal Investigator, Affiliation: Nanfang Hospital,Southern Medical University

Overall contact:
Jinlin Hou, MD, Phone: 86-20-61641941, Email: jlhousmu@yahoo.com.cn

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

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

serum HBV DNA reduction from baseline at week 104

The proportion of subjects with ALT normalization at week 104

The proportion of subjects with HBeAg loss and seroconversion at week 104

The proportion of subject with HBsAg loss and seroconversion at week 104

The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

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.

Jinlin Hou, MD, Phone: 86-20-61641941, Email: jlhousmu@yahoo.com.cn

Beijing Ditan Hospita, Beijing, Beijing, China; Not yet recruiting
Jun Cheng, MD, Phone: 13701223262
Jun Cheng, MD, Principal Investigator

Beijing Friendship Hospital Attached to the Capital Medical University, Beijing, Beijing, China; Recruiting
Hong Ma, MD, Phone: 13651096128
Hong Ma, MD, Principal Investigator

Department of infectious disease, First Hospital of Peking University, BeiJing, Beijing, China; Recruiting
YanYan Yu, MD, Phone: 13901194223
Yanyan Yu, MD, Principal Investigator

People'S Hospital Under Beijnig University, Beijing, Beijing, China; Not yet recruiting
Hao Wang, MD, Phone: 13801051583
Hao Wang, Principal Investigator

The First Affiliated Hospital of Fujian Medical University, FuZhou, Fujian, China; Not yet recruiting
JiaJi Jiang, MD, Phone: 15980631112
JiaJi Jiang, MD, Principal Investigator

The First People's Hospital of Foshan, FoShan, Guangdong, China; Recruiting
HongTao Luo, MD, Phone: 13927799608
HongTao Luo, MD, Principal Investigator

Department of infectious disease, Nanfang Hospital, GuangZhou, Guangdong, China; Recruiting
JinLin Hou, MD, Phone: 86-20-61641941, Email: jlhou@fimmu.com
JinLin Hou, MD, Principal Investigator

GuangDong Provincial People's hospital, GuangZhou, Guangdong, China; Not yet recruiting
XiaoPing Chen, MD, Phone: 13527880595
XiaoPing Chen, MD, Principal Investigator

First Affiliated Hospital of Guangxi Medical University, NanNing, Guangxi, China; Not yet recruiting
JianNing Jiang, MD, Phone: 13907719786
JianNing Jiang, MD, Principal Investigator

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology, Wuhan, Hubei, China; Not yet recruiting
Qing Ning, MD, Phone: 13971521450
Qing Ning, Principal Investigator

Xiangya Hospital Central-South Univrsity, ChangSha, Hunan, China; Not yet recruiting
DeMing Tan, MD, Phone: 13875986817
DeMing Tan, MD, Principal Investigator

First Hospital .Jilin Unniversity, ChangChun, Jilin, China; Recruiting
JunQi Niu, MD, Phone: 13756661205
JunQi Niu, Principal Investigator

ShengJing Hospital of China Medical University, ShenYang, Liaoning, China; Recruiting
XiaoGuang Dou, MD, Phone: 13898867074
XiaoGuang Dou, Principal Investigator

Changhai Hospital affiliated to Second Military Medical University, ShangHai, Shanghai, China; Not yet recruiting
MoBin Wan, MD, Phone: 13801678857
MoBin Wan, Principal Investigator

Huashan Hospital，Fudan University, ShangHai, Shanghai, China; Not yet recruiting
GuangFeng Shi, MD, Phone: 13817780666
GuangFeng Shi, MD, Principal Investigator

Shanghai Ruijin Hospital, ShangHai, Shanghai, China; Recruiting
Qing Xie, MD, Phone: 13651804273
Qing Xie, Principal Investigator

Starting date: December 2010
Last updated: October 16, 2012