3E Extension Study (3E Ex)

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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Hepatitis B
• Intervention / Treatment: Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • 302 Military Hospital of China
    • Beijing, Beijing, China
      • Beijing Ditan Hospita
    • Beijing, Beijing, China
      • Beijing Friendship Hospital Attached to the Capital Medical University
    • Beijing, Beijing, China
      • BeiJing YouAn Hospital ,Capital Medical University
    • Beijing, Beijing, China
      • Department of infectious disease, First Hospital of Peking University
    • Beijing, Beijing, China
      • People'S Hospital Under Beijnig University
  • Chongqing
    • Chongqing, Chongqing, China
      • The Second Affiliated of ChongQing University of Medical Science
  • Fujian
    • FuZhou, Fujian, China
      • The First Affiliated Hospital of Fujian Medical University
  • Guangdong
    • FoShan, Guangdong, China
      • The First People's Hospital of Foshan
    • GuangZhou, Guangdong, China
      • Guangdong Provincial People's Hospital
    • Guangzhou, Guangdong, China
      • Department of Infectious Disease, Nanfang Hospital
    • Guangzhou, Guangdong, China
      • No. 8 People's Hospital In GuangZhou
    • Guangzhou, Guangdong, China
      • The Third Hospital of Sun Yat-Sen University
  • Guangxi
    • NanNing, Guangxi, China
      • First Affiliated Hospital of Guangxi Medical University
  • Hubei
    • Wuhan, Hubei, China
      • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
  • Hunan
    • Changsha, Hunan, China
      • Xiangya Hospital Central-South Univrsity
  • Jiangsu
    • Nanjing, Jiangsu, China
      • No.81 Hospital of PLA
  • Jilin
    • Changchun, Jilin, China
      • First Hospital .Jilin Unniversity
  • Liaoning
    • Shengyang, Liaoning, China
      • Shengjing Hospital of China Medical University
  • Shandong
    • Jinan, Shandong, China
      • JiNan Infectious Diseases Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Changhai Hospital affiliated to Second Military Medical University
    • Shanghai, Shanghai, China
      • Huashan Hospital，Fudan University
    • Shanghai, Shanghai, China
      • No.85 Hospital of PLA
    • Shanghai, Shanghai, China
      • Shanghai Ruijin Hospital
  • Shanxi
    • XiAn, Shanxi, China
      • Tangdu Hospital
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital.SiChuan University
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • HangZhou No.6 People Hospital
    • Hangzhou, Zhejiang, China
      • The First Affiliated Hospital of College of Medicine, Zhejiang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment group	Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentages of patients achieving HBV DNA< 300copies/mL at week 144	Week 144

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96	Week 48 & 96
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144	Week 48 & 96 &144
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.	Week 48 & 96 & 144
Percentage of patients with ALT normalization at week 48/96/144	Week 48 & 96 & 144

Collaborators and Investigators

• Sponsor: Nanfang Hospital of Southern Medical University
• Collaborators: Major Science and Technology Special Project of China 12th Five-year

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: April 14, 2013
• First Submitted That Met QC Criteria: April 17, 2013
• First Posted (Estimate): April 18, 2013

Study Record Updates

• Last Update Posted (Estimate): June 19, 2014
• Last Update Submitted That Met QC Criteria: June 17, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Experienced Treatment
• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Chronic; Hepatitis; Hepatitis B; Hepatitis B, Chronic; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Reverse Transcriptase Inhibitors; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Entecavir; Adefovir
• Other Study ID Numbers: MOH-07