The purpose of this study is to demonstrate that long-term treatment (up to six years) with telbivudine or telbivudine plus adefovir results in the regression in liver inflammation and fibrosis/cirrhosis.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Telbivudine, 600mg, oral, daily
Adefovir dipivoxil 10mg, oral, daily
302 Military Hospital Of China
Beijing, Beijing Municipality, China
Percentage of patients with histological improvement (≥2-point decrease in the Knodell necroinflammatory score and no worsening in Ishak fibrosis score).
Time frame: Week 48
Percentage of patients achieving hepatitis B virus (HBV) DNA <300copies/mL at week 48 and 96 in on-treatment group
Time frame: week 48, week 96
Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48 and 96 in on-treatment group
Time frame: week 48, week 96
Percentage of patients with HBsAg loss or HBsAg seroconversion at week 48 and 96 in on-treatment group
Time frame: week 48, week 96
The percentage of patients with alanine aminotransferase (ALT) normalization at week 48 and 96 in on-treatment group
Time frame: week 48, week 96
Percentage of patients with HBV DNA breakthrough at week 48 and 96 in on-treatment group
Time frame: week 48, week 96
Percentage of patients with genotypic resistance among the patients with HBV DNA breakthrough at week 48 and 96 in on-treatment group
Time frame: week 48, week 96
Incidence of adverse effect at week 48 and 96 in on-treatment group
Time frame: week 48, week 96
Percentage of patients with glomerular filtration rate (GFR) shifting to >90 mL/min/1.73 m2 for patients with GFR <90 mL/min/1.73 m2 at baseline of EFFORT study at week 48 and 96 in on-treatment group
Time frame: week 48, week 96
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Beijing Ditan Hospital
Beijing, Beijing Municipality, China
BeiJing YouAn Hospital ,Capital Medical University
Beijing, Beijing Municipality, China
Department of infectious disease, First Hospital of Peking University
Beijing, Beijing Municipality, China
People's Hospital of Beijing University
Beijing, Beijing Municipality, China
The Second Affiliated of ChongQing University of Medical Science
Chongqing, Chongqing Municipality, China
Department of Infectious Disease, Nanfang Hospital
Guangzhou, Guangdong, China
No. 8 People's Hospital In GuangZhou
Guangzhou, Guangdong, China
The Third Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
...and 10 more locations
Sustained response rate of durability of HBeAg seroconversion at week 48 and 96 in off-treatment group
Time frame: week 48, week 96
Percentage of patients who re-achieved ALT normalization and HBV DNA <300 copies/mL in the patients retreated who developed hepatitis flare after stopping treatment in off-treatment group
Time frame: week 96
Incidence of abnormal laboratory examination at week 48 and 96 in on-treatment group
Time frame: week 48, week 96
Percentage of hepatitis flare at week 48 and 96 in off-treatment group
Time frame: week 48, week 96