Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
NCT ID: NCT01341743
Last Updated: 2013-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
360 participants
INTERVENTIONAL
2010-12-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
oral entecavir 1mg daily for 104 weeks
Entecavir
patients will receive oral entecavir 1mg, daily for 104 weeks.
B
oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
Entecavir, Adefovir
patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
C
oral entecavir 0.5mg 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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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 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;
18 Years
65 Years
ALL
No
Sponsors
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JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
UNKNOWN
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Principal Investigators
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JinLin Hou, MD
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Beijing Ditan Hospita
Beijing, Beijing Municipality, China
Beijing Friendship Hospital Attached to the Capital Medical University
Beijing, Beijing Municipality, China
Department of infectious disease, First Hospital of Peking University
Beijing, Beijing Municipality, China
People'S Hospital Under Beijnig University
Beijing, Beijing Municipality, 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
First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Xiangya Hospital Central-South Univrsity
Changsha, Hunan, China
First Hospital .Jilin Unniversity
Changchun, Jilin, China
ShengJing Hospital of China Medical University
Shenyang, Liaoning, China
Changhai Hospital affiliated to Second Military Medical University
Shanghai, Shanghai Municipality, China
Huashan Hospital，Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Ruijin Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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MOH-04
Identifier Type: -
Identifier Source: org_study_id