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

This study is currently recruiting participants.
Verified October 2012 by Nanfang Hospital of Southern Medical University
Sponsor:
Collaborator:
JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
Information provided by:
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01341743
First received: February 16, 2011
Last updated: April 26, 2013
Last verified: October 2012
History of Changes
  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:

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
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
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 May 19, 2013