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

Chronic Hepatitis B Clinical Trial

— Dragon-Ex  

Official title:

A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Therapy for Patients Previously Treated in Dragon Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01829685
• Other study ID #: MOH-06
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 9, 2013
• Last updated: June 17, 2014
• Start date: March 2013

Study information

• Verified date: June 2014
• Source: Nanfang Hospital of Southern Medical University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Inadequate Response
• Nucleos(t)Ide Analogues Treatment

Intervention

Drug:
• Entecavir, Adefovir

Locations

Country	Name	City	State
China	Beijing Ditan Hospital	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	First Hospital .Jilin Unniversity	Changchun	Jilin
China	Xiangya Hospital Central-South Univrsity	Changsha	Hunan
China	The First People's Hospital of Foshan	FoShan	Guangdong
China	The First Affiliated Hospital of Fujian Medical University	FuZhou	Fujian
China	Department of Infectious Disease, Nanfang Hospital	Guangzhou	Guangdong
China	GuangDong Provincial People's hospital	GuangZhou	Guangdong
China	First Affiliated Hospital of Guangxi Medical University	NanNing	Guangxi
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	ShengJing Hospital of China Medical University	Shengyang	Liaoning
China	Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (2)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Major Science and Technology Special Project of China Eleventh Five-year

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group		Week 144	No
Secondary	Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group.		Week 48 & 96	No
Secondary	The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144.		Week 48 & 96 &144	No
Secondary	Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144.		Week 48 & 96 & 144	No
Secondary	Percentage of patients with ALT normalization at week 48/96/144		Week 48 & 96 & 144	No