3E Extension Study

This study is currently recruiting participants.
Verified April 2013 by Nanfang Hospital of Southern Medical University
Sponsor:
Collaborator:
Major Science and Technology Special Project of China 12th Five-year
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01834508
First received: April 14, 2013
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.


Condition Intervention Phase
Chronic Hepatitis B
Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Plus Adefovir Combination Treatment for Patients Previously Treated in EXPLORE, EXCEL and EFFORT Ex Study

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Percentages of patients achieving HBV DNA< 300copies/mL at week 144 [ Time Frame: Week 144 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 [ Time Frame: Week 48 & 96 ] [ Designated as safety issue: No ]
  • The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144 [ Time Frame: Week 48 & 96 &144 ] [ Designated as safety issue: No ]
  • Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144. [ Time Frame: Week 48 & 96 & 144 ] [ Designated as safety issue: No ]
  • Percentage of patients with ALT normalization at week 48/96/144 [ Time Frame: Week 48 & 96 & 144 ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: March 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment group Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks

  Eligibility

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

Inclusion Criteria:

  • Subjects who completed the EXPLORE or EXCEL studies, or subjects with hepatitis flare after treatment withdrawal in EFFORT study.
  • Subjects who are willing to participate the extension study.

Exclusion Criteria:

  • Subjects who could not compliance with the protocol judged by investigators
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834508

Contacts
Contact: Jinlin Hou, MD 86-20-61641941 jlhousmu@yahoo.com.cn

  Hide Study Locations
Locations
China, Beijing
302 Military Hospital Of China Recruiting
Beijing, Beijing, China
Contact: Hongfei Zhang    13311178668      
Principal Investigator: Hongfei Zhang         
Beijing Ditan Hospita Recruiting
Beijing, Beijing, China
Contact: Jun Cheng    13701223262      
Principal Investigator: Jun Cheng         
Beijing Friendship Hospital Attached To The Capital Medical University Recruiting
Beijing, Beijing, China
Contact: Hong Ma    13651096128      
Principal Investigator: Hong Ma         
BeiJing YouAn Hospital ,Capital Medical University Recruiting
Beijing, Beijing, China
Contact: Xinyue Chen    13911212398      
Principal Investigator: Xinyue Chen         
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 Recruiting
Beijing, Beijing, China
Contact: Hao Wang    13801051583      
Principal Investigator: Hao Wang         
China, Chongqing
The Second Affiliated of ChongQing University of Medical Science Recruiting
Chongqing, Chongqing, China
Contact: Hong Ren    13983888786      
Principal Investigator: Hong Ren         
China, Fujian
The First Affiliated Hospital of Fujian Medical University 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      
Principal Investigator: Jinlin Hou, MD         
Sub-Investigator: Jian Sun, MD         
GuangDong Provincial People's hospital Recruiting
GuangZhou, Guangdong, China
Contact: XiaoPing Chen, MD    13527880595      
Principal Investigator: XiaoPing Chen, MD         
No. 8 People's Hospital In GuangZhou Recruiting
Guangzhou, Guangdong, China
Contact: Min Xu    13802969935      
Principal Investigator: Min Xu         
The Third Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China
Contact: Zhiliang Gao    13902263533      
Principal Investigator: Zhiliang Gao         
China, Guangxi
First Affiliated Hospital of Guangxi Medical University 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 Recruiting
Wuhan, Hubei, China
Contact: Qin Ning    13971521450      
Principal Investigator: Qin Ning         
China, Hunan
Xiangya Hospital Central-South Univrsity Recruiting
Changsha, Hunan, China
Contact: Deming Tan    13975886582      
Principal Investigator: Deming Tan         
China, Jiangsu
No.81 Hospital of PLA Recruiting
Nanjing, Jiangsu, China
Contact: Maorong Wang    13401935666      
Principal Investigator: Maorong Wang         
China, Jilin
First Hospital .Jilin Unniversity Recruiting
Changchun, Jilin, China
Contact: Junqi Niu    13756661205      
Principal Investigator: Junqi Niu         
China, Liaoning
ShengJing Hospital of China Medical University Recruiting
Shengyang, Liaoning, China
Contact: Xiaoguang Dou    13898867074      
Principal Investigator: Xiaoguang Dou         
China, Shandong
JiNan Infectious Diseases Hospital Recruiting
Jinan, Shandong, China
Contact: Shijun Chen    13335153216      
Principal Investigator: Shijun Chen         
China, Shanghai
Changhai Hospital affiliated to Second Military Medical University Recruiting
Shanghai, Shanghai, China
Contact: Mobin Wan    13801678857      
Principal Investigator: Mobin Wan         
Huashan Hospital,Fudan University Recruiting
Shanghai, Shanghai, China
Contact: Guangfeng Shi    13817780666      
Principal Investigator: Guangfeng Shi         
No.85 Hospital of PLA Recruiting
Shanghai, Shanghai, China
Contact: Chengwei Chen    13401935666      
Principal Investigator: Chengwei Chen         
Shanghai Ruijin Hospital Recruiting
Shanghai, Shanghai, China
Contact: Qing Xie    13651804273      
Principal Investigator: Qing Xie         
China, Shanxi
Tangdu Hospital Recruiting
XiAn, Shanxi, China
Contact: YongTao Sun, MD    13572972619      
Principal Investigator: YongTao Sun, MD         
Tangdu Hospital Recruiting
Xian, Shanxi, China
Contact: Xuefan Bai    13572229209      
Principal Investigator: Xuefan Bai         
China, Sichuan
West China Hospital.SiChuan University Recruiting
Chengdu, Sichuan, China
Contact: Hong Tang    13550097722      
Principal Investigator: Hong Tang         
China, Zhejiang
HangZhou No.6 People Hospital Recruiting
Hangzhou, Zhejiang, China
Contact: GuoQiang Lou, MD    13605700955      
Principal Investigator: GuoQiang Lou, MD         
The First Affiliated Hospital of College of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China
Contact: Jifang Sheng    13600519200      
Principal Investigator: Jifang Sheng         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Major Science and Technology Special Project of China 12th Five-year
  More Information

No publications provided

Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01834508     History of Changes
Other Study ID Numbers: MOH-07
Study First Received: April 14, 2013
Last Updated: April 17, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Nanfang Hospital of Southern Medical University:
Experienced Treatment

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 April 20, 2014