Efficacy Optimizing Research of Lamivudine Therapy

Compensated Chronic Hepatitis B Clinical Trial

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Official title:

A Prospective, Randomised, Open-label, Multi-centre Study to Compare Three Chronic Hepatitis B (CHB) Treatment Strategies Over a 2year Period in Chinese HBeAg Positive CHB Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088009
• Other study ID #: MOH-02
• Status: Completed
• Phase: Phase 4
• First received: March 15, 2010
• Last updated: October 28, 2013
• Start date: March 2010
• Est. completion date: May 2013

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 compare the adefovir early add-on to rescue therapy strategy, and also explore the efficacy of Lamivudine and adefovir de-novo combination therapy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 366
• Est. completion date: May 2013
• Est. primary completion date: February 2013
• 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 and HBeAg positive at study screening; Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months;

Exclusion Criteria:

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

• other protocol defined inclusion/exclusion criteria

Study Design

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

Related Conditions & MeSH terms

• Compensated Chronic Hepatitis B
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• lamivudine
patients in this arm will receive oral lamivudine 100mg,daily for 24 weeks; if patients with HBV DNA higher than 1000 copies/ml at week 24, add on adefovir to week 104; otherwise, keep lamivudine monotherapy to week 104
• lamivudine
Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
• lamivudine, adefovir
patients in this arm will receive oral lamivudine 100mg daily and adefovir 10mg 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	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	Beijing	Beijing
China	First Hospital .Jilin Unniversity	ChangChun	Jilin
China	Xiangya Hospital Central-South Univrsity	ChangSha	Hunan
China	West China Hospital.SiChuan University	ChengDu	Sichuan
China	The Second Affiliated of ChongQing University of Medical Science	ChongQing	Chongqing
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	HangZhou No.6 People Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital of College of Medicine ,Zhejiang University	HangZhou	Zhejiang
China	JiNan Infectious Diseases Hospital	JINan	Shandong
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	No.85 Hospital of PLA	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
China	Tangdu Hospital	XiAn	Shanxi

Sponsors (3)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	GlaxoSmithKline, 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	the proportion of virological breakthrough with confirmed Lamivudine resistant mutants		during 104 weeks study period	No
Secondary	proportion of subjects with hepatitis B virus (HBV) DNA=300 copies/mL		week 104	No
Secondary	Reduction of serum HBV DNA level from baseline (log10 copies/mL) to week 104		baseline, week 104	No
Secondary	The proportion of subjects with ALT normalization at week 104		week 104	No
Secondary	The proportion of subjects with HBeAg loss and seroconversion at week 104		week 104	No
Secondary	The proportion of subjects with HBsAg loss and seroconversion rates at week 104		week 104	No