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

Hepatitis B Clinical Trial

Official title:

A Multi-center, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Generic Entecavir Monotherapy or in Combination With Adefovir for Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01341743
• Other study ID #: MOH-04
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 16, 2011
• Last updated: October 28, 2013
• Start date: December 2010
• Est. completion date: December 2014

Study information

• Verified date: September 2013
• 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 evaluate the efficacy and safety of generic entecavir monotherapy or in combination with adefovir for chronic hepatitis B patients with inadequate response to NUC therapy

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 360
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female aged 18-65 years;

• Capable of understanding and signing the informed consent. Willing to comply with the study requirements;

• Serum HBsAg positive and ALT<10ULN at study screening;

• Patients have been treated with one nucleoside/nucleotide analogue for more than 6 months and are still on treatment;

Exclusion Criteria:

• History of viral breakthrough or genotypic resistance on previous therapy;

• History of decompensated liver function, or current signs/symptoms of decompensation e.g. ascites, variceal bleeding, encephalopathy or spontaneous peritonitis;

• Patient has a history of hepatocellular carcinoma(HCC) or findings suggestive of possible HCC;

• Other protocol defined exclusion criteria.

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Entecavir
patients will receive oral entecavir 1mg, daily for 104 weeks.
• Entecavir, Adefovir
patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
• Entecavir, Adefovir
patients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks

Locations

Country	Name	City	State
China	Beijing Ditan Hospita	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	ShenYang	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	JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104		week 104	No
Secondary	serum HBV DNA reduction from baseline at week 104		week 104	No
Secondary	The proportion of subjects with ALT normalization at week 104		week104	No
Secondary	The proportion of subjects with HBeAg loss and seroconversion at week 104		week104	No
Secondary	The proportion of subject with HBsAg loss and seroconversion at week 104		week104	No
Secondary	The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104		week104	No