Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy (Dragon-Ex)

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 Eleventh Five-year
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier:
NCT01829685
First received: April 9, 2013
Last updated: NA
Last verified: April 2013
History: No changes posted
  Purpose

The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy


Condition Intervention Phase
Chronic Hepatitis B
Inadequate Response
Nucleos(t)Ide Analogues Treatment
Drug: Entecavir, Adefovir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Therapy for Patients Previously Treated in Dragon 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 in each group [ Time Frame: Week 144 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group. [ 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: 360
Study Start Date: March 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Group I
oral entecavir 1mg daily and adefovir 10mg daily for 144 weeks
Drug: Entecavir, Adefovir
Active Comparator: Group II
oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks
Drug: Entecavir, Adefovir

  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 104-week Dragon 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: NCT01829685

Contacts
Contact: Jinlin Hou, MD 86-20-61641941 jlhousmu@yahoo.com.cn
Contact: Jian Sun 86-20-62787432 sunjian@fimmu.com

Locations
China, Beijing
Department of infectious disease, First Hospital of Peking University Recruiting
Beijing, Beijing, China
Contact: Yanyan Yu, MD    13901194223      
Principal Investigator: Yanyan Yu, MD         
Beijing Ditan Hospital Recruiting
Beijing, Beijing, China
Contact: Jun Cheng, MD         
Principal Investigator: Jun Cheng, MD         
Beijing Friendship Hospital Attached To The Capital Medical University Recruiting
Beijing, Beijing, China
Contact: Hong Ma    13651096128      
Principal Investigator: Hong Ma         
People's Hospital Under Beijnig University Recruiting
Beijing, Beijing, China
Contact: Hao Wang    13801051583      
Principal Investigator: Hao Wang         
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         
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: Qing Ning, MD    13971521450      
Principal Investigator: Qing Ning         
China, Hunan
Xiangya Hospital Central-South Univrsity Recruiting
Changsha, Hunan, China
Contact: Deming Tan    13975886582      
Principal Investigator: Deming Tan         
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, 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         
Shanghai Ruijin Hospital Recruiting
Shanghai, Shanghai, China
Contact: Qing Xie    13651804273      
Principal Investigator: Qing Xie         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Major Science and Technology Special Project of China Eleventh Five-year
Investigators
Principal Investigator: Jinlin Hou, MD Nanfang Hospital of Southern Medical University
  More Information

No publications provided

Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT01829685     History of Changes
Other Study ID Numbers: MOH-06
Study First Received: April 9, 2013
Last Updated: April 9, 2013
Health Authority: China: Food and Drug Administration

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 17, 2014