This is a phase three study to evaluate the safety and efficacy of Pradefovir treatment in chronic hepatitis B patients. Subject will be randomized to Pradefovir group and TDF group at a ratio of 2:1. Treatment duration will be 96w in randomization and followed by 48w in open. The interim analysis will be conducted when all subject completed the first 48-week treatment.
this is a randomized, double-blind, positive drug parallel control, multicenter, phase 3 study .Eligible HBeAg-positive or HBeAg-negative chronic hepatitis B patients will be stratified by historical antiviral treatment (untreated or treated) at the time of screening, and then randomly assigned to Pradefovir mesylate tablet group or tenofovir disoproxil fumarate tablet group at a ratio of 2:1. The proportion of subject with compensatory stage of cirrhosis is no more than 20 percentage. Patients will receive a total of 144 weeks of antiviral treatments, and after 96 weeks of double-blind treatment, all subjects will switch to open mesylate Pradefovir tablets for additional 48 weeks. The first 48 weeks are the core period and the followed 96 weeks are the extension period. Statistical analysis was conducted on the efficacy and safety of the whole trial. (After the completion of 48-week visit of the last one subject, the interim analysis will be conducted. The analysts will be unblinded, while the remaining participants will still be blind.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
900
The First Hospital of Jilin University
Changchun, Jilin, China
RECRUITINGHBV viral suppression
proportion of patients with hepatitis B virus(HBV) -DNA undetectable(\<29IU/ml)
Time frame: After 48-week therapy
HBV viral suppression
proportion of patients with hepatitis B virus(HBV) -DNA undetectable(\<29IU/ml)
Time frame: After therapy of 4, 8, 12, 24, 36, 72, 96, 144 weeks
HBV viral suppression
proportion of patients with hepatitis B virus(HBV) -DNA undetectable(\<20IU/ml)
Time frame: After therapy of 4, 8, 12, 24, 48, 36, 72, 96, 144 weeks
The reduction of HBV DNA load
the change of HBV DNA load from baseline
Time frame: at week 4, 8, 12, 24, 36, 48, 72, 96, 144
ALT normalization
proportion of patients with ALT normalization
Time frame: After therapy of 4, 8, 12, 24, 48, 36, 72, 96, 144 weeks
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