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

Phase 4

• Conditions: Chronic Hepatitis B; Inadequate Response; Nucleos(t)Ide Analogues Treatment
• Interventions: Drug: Entecavir, Adefovir

• Registration Number: NCT01829685
• Lead Sponsor: Nanfang Hospital, Southern Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-04-09
• Study First Submitted QC: 2013-04-09
• Study First Posted: 2013-04-11
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-19
• Primary Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group I	Entecavir, Adefovir	oral entecavir 1mg daily and adefovir 10mg daily for 144 weeks
Group II	Entecavir, Adefovir	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 in each group	Week 144

Secondary Outcome Measures

Name	Time	Method
Percentage of patients with ALT normalization 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
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group.	Week 48 & 96
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144.	Week 48 & 96 &144

Trial Locations

Locations (16)

Beijing Ditan Hospital; 🇨🇳 Beijing, Beijing, China

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

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

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

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

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

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

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

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

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

Shanghai Ruijin Hospital; 🇨🇳 Shanghai, Shanghai, China

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

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

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

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

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