This is an evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety of multicenter, randomized, open label clinical trial.
evaluation of adenosine methionine for treatment of chronic hepatitis b patients with cholestasis efficacy and safety
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Ademetionine 1000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 500mg po bid with general antiviral treatment for 8 weeks
Ademetionine 2000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
Public Health Clinical Center Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGlevels of serum total bilirubin declined from baseline
levels of serum total bilirubin declined from baseline
Time frame: 2 weeks
Alkaline Phosphatase
Alkaline Phosphatase
Time frame: 10 weeks
Gamma-Glutamyl Transpeptidase
Gamma-Glutamyl Transpeptidase
Time frame: 10 weeks
level of serum direct bilirubin decline from baseline
level of serum direct bilirubin decline from baseline
Time frame: 2 weeks, 6 weeks, 10 weeks
level of serum bile acids decline from baseline
level of serum bile acids decline from baseline
Time frame: 2 weeks, 6 weeks, 10 weeks
glutamic pyruvic transaminase
glutamic pyruvic transaminase
Time frame: 2 weeks, 6 weeks, 10 weeks
glutamic oxaloacetic transaminase
glutamic oxaloacetic transaminase
Time frame: 2 weeks, 6 weeks, 10 weeks
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