liver cirrhosis related to Hepatitis B
Conditions
Interventions
patients with different types of decompensated hepatitis B cirrhosis:Nil
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Aged >= 18 and <= 70 years; (2) No gender limitation; (3) According to the 2015 Guidelines for the Prevention and Treatment of Chronic Hepatitis B, it meets the diagnostic criteria for cirrhosis (with clinical, biochemical, hematological, imaging, or histological evidence of cirrhosis), and HBV DNA is positive at the time of screening; (4) Ascites and/or hepatic encephalopathy occurred during screening or within the first six months of enrollment; (5) Long-term follow-up; (6) Sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) Chronic liver disease caused by non-HBV causes (such as HCV infection, alcoholic liver disease, severe fatty liver, drug-induced liver injury, autoimmune liver disease, genetic metabolic liver disease, etc.); (2) Those allergic to entecavir and its pharmaceutical ingredients; (3) Patients who are resistant to lamivudine and telbivudine; (4) Hepatic encephalopathy of grade 3 and above; (5) There are other decompensated manifestations of liver cirrhosis, including gastrointestinal bleeding, hepatorenal syndrome, hepatopulmonary syndrome; (6) Chronic liver failure or chronic plus acute liver failure; (7) Child-Pugh score is greater than 12 points; (8) AFP >= 100ng/ml or Cr is 1.5 times higher than the upper limit of normal value during screening; (9) Patients with malignant tumors (excluding those who have been cured, including primary liver cancer); (10) Patients with severe diseases of visceral organs such as heart, lung, kidney, brain, blood, etc. with dysfunction; (11) Patients with severe mental illness (such as depression, mania, seizures, schizophrenia, etc.); (12) Pregnant women and lactating women; (13) The patient has poor compliance and is unable to complete the follow-up requirements; (14) The investigator thinks it is not suitable to participate in this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The Incidence of clinical endpoints;Virology, Serology and Biochemistry;Child-Pugh, MELD score;Fibroscan;Hospital costs; | — |
Primary
| Measure | Time frame |
|---|---|
| The incidence of recompensation after 1 year of treatment (without decompensation in 1 year); | — |
Countries
China
Contacts
Public ContactWen Xie
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed