The study objective is to evaluate the safety and effectiveness of different doses of Metacavir Enteric-coated Capsules in treatment of chronic hepatitis B,as well as to find an appropriate clinical dosage by comparing the effect of different doses of treatment,in order to provide references of clinical trial of the next phase.
180 eligible subjects will be included.According to the set grouping method of dose escalation.Subjects will be randomized in a 1:1:1:1 proportion of Metacavir Enteric-coated Capsules(80mg/160mg/320mg) group,positive control group or placebo control group.Each group has 36 subjects. 1.Subjects will use the study medication(2 hours before or after meal,once a day) from Visit 3 to Visit 5. 1. Metacavir Enteric-coated Capsules 80mg Group:Metacavir Enteric-coated Capsules 80mg,Metacavir Enteric-coated Capsules Placebo 240mg,Adefovir Dipivoxil Capsule Placebo 10mg; 2. Metacavir Enteric-coated Capsules 160mg Group:Metacavir Enteric-coated Capsules 160mg,Metacavir Enteric-coated Capsules Placebo 160mg,Adefovir Dipivoxil Capsule Placebo 10mg; 3. Metacavir Enteric-coated Capsules 320mg Group:Metacavir Enteric-coated Capsules 320mg,Adefovir Dipivoxil Capsule Placebo 10mg; 4. Positive Control(Adefovir Dipivoxil Capsule) Group:Metacavir Enteric-coated Capsules Placebo 320mg,Adefovir Dipivoxil Capsule 10mg; 5. Placebo Control Group:Metacavir Enteric-coated Capsules Placebo 320mg,Adefovir Dipivoxil Capsule Placebo 10mg;
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
180
Metacavir Enteric-coated Capsules 80mg
Metacavir Enteric-coated Capsules 160mg
Metacavir Enteric-coated Capsules 320mg
81 Military Hospital of China
Nanjing, Jiangsu, China
RECRUITINGThe change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment.
The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment.(Unit:log10)
Time frame: 12 weeks
Incidence of treatment-chronic hepatitis B
1. The proportion of subjects whose HBV-DNA are down to double logarithms at Week 12 of treatment.(Unit:%) 2. The proportion of subjects whose HBV-DNA are not detected or less than upper limit of normal at Week 12 of treatment.(Unit:%) 3. The proportion of subjects (HBeAg positive at baseline) whose is changed at Week 12 of treatment.(Unit:%) 4. The proportion of subjects whose HBsAg is changed to negative at Week 12 of treatment.(Unit:%)
Time frame: 12 weeks
Incidence of Adverse Events(AEs)
Time frame: 48 weeks
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Metacavir Enteric-coated Capsules Placebo 240mg
Metacavir Enteric-coated Capsules Placebo 160mg
Metacavir Enteric-coated Capsules Placebo 320mg
Adefovir Dipivoxil Capsule10mg
Adefovir Dipivoxil Capsule Placebo 10mg