Clinical trial NCT01341743: Efficacy Optimizing Research of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B
Keywords: chronic hepatitis B
inadequate response
NUC therapy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: JiangSu Chia-Tai Tianqin Pharmacy Co.Ltd
First posted: 2011-04-26
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: 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.

Primary outcomes:
measure: proportion of subjects with hepatitis B virus (HBV)DNA<300copies/ml at week 104
timeFrame: week 104
Secondary outcomes:
measure: serum HBV DNA reduction from baseline at week 104
timeFrame: week 104
measure: The proportion of subjects with ALT normalization at week 104
timeFrame: week104
measure: The proportion of subjects with HBeAg loss and seroconversion at week 104
timeFrame: week104
measure: The proportion of subject with HBsAg loss and seroconversion at week 104
timeFrame: week104
measure: The proportion of subjects with mutations of rtN236T/A181V, rtL180M/rtM204V/rtT184/rtS202 and/or rtM250 at week 104
timeFrame: week104
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospita
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital Attached to the Capital Medical University
state: Beijing
city: BeiJing
country: China
facility: Department of infectious disease, First Hospital of Peking University
state: Beijing
city: Beijing
country: China
facility: People'S Hospital Under Beijnig University
state: Beijing
city: FuZhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
state: Fujian
city: FoShan
country: China
facility: The First People's Hospital of Foshan
state: Guangdong
city: GuangZhou
country: China
facility: Department of infectious disease, Nanfang Hospital
state: Guangdong
city: GuangZhou
country: China
facility: GuangDong Provincial People's hospital
state: Guangdong
city: NanNing
country: China
facility: First Affiliated Hospital of Guangxi Medical University
state: Guangxi
city: Wuhan
country: China
facility: Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
city: ChangSha
country: China
facility: Xiangya Hospital Central-South Univrsity
state: Hunan
city: ChangChun
country: China
facility: First Hospital .Jilin Unniversity
state: Jilin
city: ShenYang
country: China
facility: ShengJing Hospital of China Medical University
state: Liaoning
city: ShangHai
country: China
facility: Changhai Hospital affiliated to Second Military Medical University
state: Shanghai
city: ShangHai
country: China
facility: Huashan Hospital，Fudan University
state: Shanghai
city: ShangHai
country: China
facility: Shanghai Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: JinLin Hou, MD
role: PRINCIPAL_INVESTIGATOR
References: