Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

Conditions

Liver Cirrhosis

Keywords

Liver Cirrhosis, Hepatitis B, Compensation, Efficacy

Brief summary

Six hundreds patients with chronic hepatitis B clinically diagnosed as compensated liver cirrhosis are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year, entecavir for another additional 0.5 year.Patients will be assessed at baseline, at every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan;

Wu X, Zhou J, Sun Y, Liu C, Zhang L, Zhang X, Zhao H, Xu M, Chen Y, Piao H, Liu X, Xing H, Ding H, Yang M, Jiang W, Wang B, Chen S, Meng T, He Z, Wang H, Ou X, Jia J, You H.

2025-09-13

10.1016/j.cgh.2025.05.029

Wu X, Hong J, Zhou J, Sun Y, Li L, Xie W, Piao H, Xu X, Jiang W, Feng B, Chen Y, Xu M, Cheng J, Meng T, Wang B, Chen S, Kong Y, Ou X, You H, Jia J.

2021-11-2912 citations

10.1007/s12072-021-10240-4

Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy.

Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J.

2021-01-185 citations

10.1007/s12072-020-10114-1

Interventions

DRUGEntecavir

anti-viral therapy

DRUGThymosin-α

anti-viral and antitherapy

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

No

Inclusion criteria

1. Patients from age 18 to 65 years ; 2. Male or female; 3. Treatment-naive patients of clinically diagnosed as HBV-induced compensated cirrhosis(meet one of the following two criterions); 1. endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension 2. if no endoscopy,should meet two of the four Criterias: * Imaging (US, CT or MRI, et al) showing Surface nodularity: Echogenecity * Platelet (PLT) \< 100×10 \< 9 \>/L , no other interpretation * Albumin (ALB) \< 35.0 g/L, or International Standard Value (INR) \> 1.3 (Prothrombin Time (PT) prolonged \> 3s), or Cholinesterase (CHE) decrease * Liver stiffness measurement value \> 12.4 kpa (ALT\<5×ULN) 4. HBeAg-positive, HBVDNA \> 2×10\<3\> IU/ml or with HBeAg-negative patients, HBVDNA \> 2×10\<2\> IU/ml; 5. Agree to be followed up regularly; 6. Signature of written inform consent.

Exclusion criteria

1. Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma; 2. Patients who are allergic to entecavir, thymosin or their components, and those considered not suitable for medicine in this study; 3. Patients with HCV or HIV infection, alcoholic liver disease, autoimmune liver disease, genetic liver disease, drug-induced liver injury, severe non-alcoholic fatty liver disease or other chronic liver diseases; 4. Patients with baseline AFP level higher than 100ng/ml and possible malignant lesion on image, or AFP level higher than 100ng/ml for more than three months; 5. Creatinine \> 1.5×ULN; 6. Patients with other uncured malignant tumors; 7. Patients with severe diseases of heart, lung, kidney, brain, blood system or other organs; 8. Patients with any other reasons not suitable for the study.

Design outcomes

Primary

Measure	Time frame	Description
Decompensated rate of Liver Cirrhosis after 2 years treatment	2 years	Decompensated rate of Liver Cirrhosis (ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) after 2 years treatment.

Secondary

Measure	Time frame	Description
Child-Pugh and MELD scores	1 and 2-year	The progress of Child-Pugh and MELD scores after 1 and 2-year treatment
The HBV DNA undetectable rate	1 and 2-year	The HBV DNA undetectable rate after 1 and 2-year treatment
Liver stiffness measurement	1 and 2-year	Liver stiffness measurement change after 1 and 2-year treatment.
Quality of Life	1 and 2-year	Quality of life after 1 and 2-year treatment by SF-36 and EQ-5D questionares

Countries

China

Outcome results

None listed