Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy - Full Text View

Purpose

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

Condition	Intervention	Phase
Hepatitis B	Drug: Entecavir Drug: Entecavir, Adefovir	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis A Hepatitis B

Drug Information available for: Entecavir Adefovir dipivoxil Recombinant Hepatitis B vaccine Hepatitis A Vaccines

U.S. FDA Resources

Further study details as provided by Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:

proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

serum HBV DNA reduction from baseline at week 104 [ Time Frame: week 104 ] [ Designated as safety issue: No ]
The proportion of subjects with ALT normalization at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
The proportion of subjects with HBeAg loss and seroconversion at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
The proportion of subject with HBsAg loss and seroconversion at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]
The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104 [ Time Frame: week104 ] [ Designated as safety issue: No ]

Estimated Enrollment:	360
Study Start Date:	December 2010
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A oral entecavir 1mg daily for 104 weeks	Drug: Entecavir patients will receive oral entecavir 1mg, daily for 104 weeks.
Active Comparator: B oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks	Drug: Entecavir, Adefovir patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
Active Comparator: C oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks	Drug: Entecavir, Adefovir patients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341743

Contacts

Contact: Jinlin Hou, MD	86-20-61641941	jlhousmu@yahoo.com.cn
Contact: Jian Sun, MD	86-20-62787432	doctorsunjian@163.com

Locations

China, Beijing
Beijing Ditan Hospita	Not yet recruiting
Beijing, Beijing, China
Contact: Jun Cheng, MD 13701223262
Principal Investigator: Jun Cheng, MD
Beijing Friendship Hospital Attached to the Capital Medical University	Recruiting
Beijing, Beijing, China
Contact: Hong Ma, MD 13651096128
Principal Investigator: Hong Ma, MD
Department of infectious disease, First Hospital of Peking University	Recruiting
BeiJing, Beijing, China
Contact: YanYan Yu, MD 13901194223
Principal Investigator: Yanyan Yu, MD
People'S Hospital Under Beijnig University	Not yet recruiting
Beijing, Beijing, China
Contact: Hao Wang, MD 13801051583
Principal Investigator: Hao Wang
China, Fujian
The First Affiliated Hospital of Fujian Medical University	Not yet recruiting
FuZhou, Fujian, China
Contact: JiaJi Jiang, MD 15980631112
Principal Investigator: JiaJi Jiang, MD
China, Guangdong
The First People's Hospital of Foshan	Recruiting
FoShan, Guangdong, China
Contact: HongTao Luo, MD 13927799608
Principal Investigator: HongTao Luo, MD
Department of infectious disease, Nanfang Hospital	Recruiting
GuangZhou, Guangdong, China
Contact: JinLin Hou, MD 86-20-61641941 jlhou@fimmu.com
Principal Investigator: JinLin Hou, MD
GuangDong Provincial People's hospital	Not yet recruiting
GuangZhou, Guangdong, China
Contact: XiaoPing Chen, MD 13527880595
Principal Investigator: XiaoPing Chen, MD
China, Guangxi
First Affiliated Hospital of Guangxi Medical University	Not yet recruiting
NanNing, Guangxi, China
Contact: JianNing Jiang, MD 13907719786
Principal Investigator: JianNing Jiang, MD
China, Hubei
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology	Not yet recruiting
Wuhan, Hubei, China
Contact: Qing Ning, MD 13971521450
Principal Investigator: Qing Ning
China, Hunan
Xiangya Hospital Central-South Univrsity	Not yet recruiting
ChangSha, Hunan, China
Contact: DeMing Tan, MD 13875986817
Principal Investigator: DeMing Tan, MD
China, Jilin
First Hospital .Jilin Unniversity	Recruiting
ChangChun, Jilin, China
Contact: JunQi Niu, MD 13756661205
Principal Investigator: JunQi Niu
China, Liaoning
ShengJing Hospital of China Medical University	Recruiting
ShenYang, Liaoning, China
Contact: XiaoGuang Dou, MD 13898867074
Principal Investigator: XiaoGuang Dou
China, Shanghai
Changhai Hospital affiliated to Second Military Medical University	Not yet recruiting
ShangHai, Shanghai, China
Contact: MoBin Wan, MD 13801678857
Principal Investigator: MoBin Wan
Huashan Hospital，Fudan University	Not yet recruiting
ShangHai, Shanghai, China
Contact: GuangFeng Shi, MD 13817780666
Principal Investigator: GuangFeng Shi, MD
Shanghai Ruijin Hospital	Recruiting
ShangHai, Shanghai, China
Contact: Qing Xie, MD 13651804273
Principal Investigator: Qing Xie

Sponsors and Collaborators

Nanfang Hospital of Southern Medical University

JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd

Investigators

Principal Investigator:

JinLin Hou, MD

Nanfang Hospital,Southern Medical University

More Information

No publications provided

Responsible Party:	Jinlin Hou, Nanfang Hospital
ClinicalTrials.gov Identifier:	NCT01341743 History of Changes
Other Study ID Numbers:	MOH-04
Study First Received:	February 16, 2011
Last Updated:	April 26, 2013
Health Authority:	China: Food and Drug Administration

Keywords provided by Nanfang Hospital of Southern Medical University:

chronic hepatitis B
inadequate response
NUC therapy

Additional relevant MeSH terms:

Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections

DNA Virus Infections
Adefovir
Adefovir dipivoxil
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents

ClinicalTrials.gov processed this record on June 18, 2013