Efficacy and safety of Entecavir plus Carnitine complex compared with entecavir monotherapy in patients with chronic hepatitis B.
Not Applicable
Recruiting
- Conditions
- Certain infectious and parasitic diseases
- Registration Number
- KCT0000084
- Lead Sponsor
- Kangbuk Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 130
Inclusion Criteria
Chronic Hepatitis B patients
- 80U/L = ALT = 10 X ULN
- HBeAg positive(HBV DNA > 100,000 copies/ml) or HBeAg negative(HBV DNA > 10,000 copies/ml)
- Never received antiviral treatment for Hepatitis B or had antiviral treatment duration of less than 3 months at least one year prior to study entry.
Exclusion Criteria
- The patient with HAV IgM Ab positive or HCV-RNA positive or HCV Ab positive
- History of hepatic coma or esophageal varices or spontaneous bacterial peritonitis or decompensated liver cirrhosis with Child-Pugh score > 10
- Presence of liver cancer or other malignant tumor
- Medical history or condition associated with chronic liver disease.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of ALT normalization
- Secondary Outcome Measures
Name Time Method The rate of combined ALT normalization and HBV DNA < 300 copies/ml;The rate of serum HBV DNA < 300 copies/ml;The changes of HBV DNA titer;The changes of HBs Ag titer;The changes of Lymphocyte activity (INF-gamma);The changes of Peripheral blood mitochondrial DNA copy number