ordecompensated HBV-related cirrhosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women patients are adults aged 18 to 65 years with hepatitis B virus related cirrhosis; 2. Evidence of active viral replication was documented by a positive test for HBV-DNA in serum; 3. Liver cirrhosis was proven by ultrasound or CT; 4. Decompensated cirrhosis was evidenced by a Child-Pugh score >= 7; 5. Patients had decompensation signs such as jaundice, ascites, variceal bleeding, and hepatic encephalopathy.
Exclusion criteria
Exclusion criteria: 1. Breastfeeding or pregnant women; 2. Use of interferon, immunomodulator, or any nucleoside analog that is active against hepatitis virus within 6months before enrollment; 3. Epilepsy or using any anti-epileptic drug; 4. Any immunologically mediated disease; 5. Malignant disease, including HCC; 6. Evidence of unstable or conspicuous angiocardiopathy such as angina cordis,heart failure,recent myocardial infarction and severe hypertension; 7. Long exposure to the hepatotoxin, such as excessive drinking(drinking greater than 14 alcohol units for more than 1 year, and 1 alcohol unit just as 1 jar of beer, or 1 cup of wine, or 1 pocillum of firewater) and drug taking; 8. Thyroid disease and diabetes that are not well controlled by drugs; 9. Liver disease that was not due to hepatitis b, as alcoholic liver disease, HCV, autoimmune disease, hemochromatosis, alpha-1 antitrypsin deficiency and Wilson’s disease; 10. Co-infection with hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV; 11. Severe kidney disease; 12. Organ transplantation (except corneal and hair transplantation); 13. Recent treatment with systemic corticosteroids; 14. Any factor that will interfere the patient to participate or complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBVM;HBVDNA;liver function; | — |
Secondary
| Measure | Time frame |
|---|---|
| kidney function;CK; | — |
Countries
China