3E Extension Study

Phase 4

• Conditions: Chronic Hepatitis B
• Interventions: Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks

• Registration Number: NCT01834508
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-14
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-18
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-19
• Primary Completion: 2016-06
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks	-

Primary Outcome Measures

Name	Time	Method
Percentages of patients achieving HBV DNA< 300copies/mL at week 144	Week 144

Secondary Outcome Measures

Name	Time	Method
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
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96	Week 48 & 96

Trial Locations

Locations (28)

Beijing Ditan Hospita; 🇨🇳 Beijing, Beijing, China

First Hospital .Jilin Unniversity; 🇨🇳 Changchun, Jilin, China

ShengJing Hospital of China Medical University; 🇨🇳 Shengyang, Liaoning, China

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China

302 Military Hospital Of China; 🇨🇳 Beijing, Beijing, China

BeiJing YouAn Hospital ,Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital Attached To The Capital Medical University; 🇨🇳 Beijing, Beijing, China

Department of infectious disease, First Hospital of Peking University; 🇨🇳 Beijing, Beijing, China

People's Hospital Under Beijnig University; 🇨🇳 Beijing, Beijing, China

The Second Affiliated of ChongQing University of Medical Science; 🇨🇳 Chongqing, Chongqing, China

The First Affiliated Hospital of Fujian Medical University; 🇨🇳 FuZhou, Fujian, China

The First People's Hospital of Foshan; 🇨🇳 FoShan, Guangdong, China

Department of Infectious Disease, Nanfang Hospital; 🇨🇳 Guangzhou, Guangdong, China

GuangDong Provincial People's hospital; 🇨🇳 GuangZhou, Guangdong, China

The Third Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Xiangya Hospital Central-South Univrsity; 🇨🇳 Changsha, Hunan, China

First Affiliated Hospital of Guangxi Medical University; 🇨🇳 NanNing, Guangxi, China

No. 8 People's Hospital In GuangZhou; 🇨🇳 Guangzhou, Guangdong, China

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Huashan Hospital，Fudan University; 🇨🇳 Shanghai, Shanghai, China

JiNan Infectious Diseases Hospital; 🇨🇳 Jinan, Shandong, China

Changhai Hospital affiliated to Second Military Medical University; 🇨🇳 Shanghai, Shanghai, China

Tangdu Hospital; 🇨🇳 XiAn, Shanxi, China

No.81 Hospital of PLA; 🇨🇳 Nanjing, Jiangsu, China

No.85 Hospital of PLA; 🇨🇳 Shanghai, Shanghai, China

West China Hospital.SiChuan University; 🇨🇳 Chengdu, Sichuan, China

HangZhou No.6 People Hospital; 🇨🇳 Hangzhou, Zhejiang, China

The First Affiliated Hospital of College of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China