Hepatitis B, Liver Cirrhosis
Conditions
Brief summary
Patients who have completed 2 years follow-up of the past National 12th Five-Year Major Project on Infectious Diseases will receive another 8 years treatment with entecavir (10 years in total). Collect serology, imaging, and other clinical data to evaluate the incidence and mortality of decompensated cirrhosis and hepatocellular carcinoma. Understand the effects of long-term antiviral therapy on HBV-induced liver fibrosis/cirrhosis.
Detailed description
Patients who have completed 2-years entecavir-based treatment in Regress Study will receive another 8 years of entecavir extension therapy. Patients will be assessed at baseline and every six months for blood cell count, liver function test, HBV-DNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan; A third liver biopsy will be performed at the 5th year of treatment in patients who have significant fibrosis at second biopsy. CT /MRI and endoscopy will be performed at baseline and the 5th and 10th year of treatment.
Interventions
DRUGEntecavir
oral entecavir 0.5mg daily for 8 years
Sponsors
Peking University People's Hospital
Fudan University
Affiliated Hospital of Yanbian University
Shanghai Public Health Clinical Center
Beijing YouAn Hospital
Nanfang Hospital, Southern Medical University
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Beijing Friendship Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\- Subjects who completed the 2 years of entecavir-based therapy in Regress study; Subjects who are willing to participate the extension study.
Exclusion criteria
\- Any complication of severe heart, lung, kidney, brain, blood diseases or other important systematic diseases; Pregnant women; Subjects who could not compliance with the protocol judged by investigators; Subjects who are not suitable for the study judged by investigators.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibrosis regression rate | year 3 | Ishak fibrosis score decrease after long-term treatment |
| Cumulative incidence of liver decompensation | year 8 | Cumulative incidence of liver decompensation (including ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) and death after long-term treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HBeAg loss or HBeAg seroconversion | year 2, 5, 7 and 10 | Percentage of patients with HBeAg loss or HBeAg seroconversion at year 2, 5, 7 and 10 |
| HBsAg loss or HBsAg seroconversion rate | year 2, 5, 7 and 10 | Percentage of patients with HBsAg loss or HBsAg seroconversion at year 2, 5, 7 and 10 |
| Dynamic changes of Child-Pugh score | year 3, 5, 7 and 10 | Dynamic changes of Child-Pugh score after 3, 5, 7 and 10 years of treatment |
| Virological response | year 3, 5, 7 and 10 | Percentage of patients achieving hepatitis B virus (HBV) DNA \< 20IU/mL at year 3, 5, 7 and 10 |
| Dynamic changes of liver stiffness values measured by Transient Elastography | year 3, 5, 7 and 10 | Dynamic changes of liver stiffness values after 3, 5, 7 and 10 years of treatment |
| Improvement of life quality (SF36 and EQ-5D) | year 3, 5, 7 and 10 | Improvement of life quality after 3, 5, 7 and 10 years of treatment |
| Dynamic changes of MELD score | year 3, 5, 7 and 10 | Dynamic changes of MELD score after 3, 5, 7 and 10 years of treatment |
| Aminotransferase response | year 3, 5, 7 and 10 | The percentage of patients with alanine aminotransferase (ALT) normalization at year 3, 5, 7 and 10 |
Countries
China
Outcome results
None listed