MedPath

Effect of Entecavir Treatment on Regression and Disease Outcome in HBV-induced Liver Fibrosis and Cirrhosis Patients

Phase 4
Active, not recruiting
Conditions
Hepatitis B
Liver Cirrhosis
Interventions
Registration Number
NCT02849132
Lead Sponsor
Beijing Friendship Hospital
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.

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
800
Inclusion Criteria
  • Subjects who completed the 2 years of entecavir-based therapy in Regress study; Subjects who are willing to participate the extension study.
Read More
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.
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Treatment groupEntecavirentecavir oral,0.5mg daily for 8 years
Primary Outcome Measures
NameTimeMethod
Fibrosis regression rateyear 3

Ishak fibrosis score decrease after long-term treatment

Cumulative incidence of liver decompensationyear 8

Cumulative incidence of liver decompensation (including ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) and death after long-term treatment

Secondary Outcome Measures
NameTimeMethod
Virological responseyear 3, 5, 7 and 10

Percentage of patients achieving hepatitis B virus (HBV) DNA \< 20IU/mL at year 3, 5, 7 and 10

Aminotransferase responseyear 3, 5, 7 and 10

The percentage of patients with alanine aminotransferase (ALT) normalization at year 3, 5, 7 and 10

HBeAg loss or HBeAg seroconversionyear 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 rateyear 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 scoreyear 3, 5, 7 and 10

Dynamic changes of Child-Pugh score after 3, 5, 7 and 10 years of treatment

Dynamic changes of MELD scoreyear 3, 5, 7 and 10

Dynamic changes of MELD score after 3, 5, 7 and 10 years of treatment

Dynamic changes of liver stiffness values measured by Transient Elastographyyear 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

Trial Locations

Locations (20)

Xijing Hospital, Fourth Military Medical University

🇨🇳

Xi'an, Shanxi, China

Beijing Friendship Hospital, Capital Medical University

🇨🇳

Beijing, Beijing, China

Beijing Tiantan Hospital, Capital Medical University

🇨🇳

Beijing, Beijing, China

Renji Hospital, Shanghai Jiao Tong University, School of Medicine

🇨🇳

Shanghai, Shanghai, China

Zhongshan Hospital Fudan University

🇨🇳

Shanghai, Shanghai, China

The Affiliated Hospital of Yanbian University

🇨🇳

Yanji, Jilin, China

The First Hospital of Shanxi Medical University

🇨🇳

Taiyuan, Shanxi, China

Beijing YouAn Hospital, Capital Medical University

🇨🇳

Beijing, Beijing, China

302 Military Hospital Of China

🇨🇳

Beijing, Beijing, China

Peking University First Hospital

🇨🇳

Beijing, Beijing, China

Shijiazhuang Fifth Hospital

🇨🇳

Shijiazhuang, Hebei, China

Peking University People's Hospital

🇨🇳

Beijing, Beijing, China

NanfangHospital,Southern Medical University

🇨🇳

Guangzhou, Guangdong, China

The Third Hospital of Hebei Medical University

🇨🇳

Shijiazhuang, Hebei, China

Tongji Hospital, Tongji Medical College , Huazhong University of Science and Technology

🇨🇳

Wuhan, Hubei, China

Shanghai Public Health Clinical Center

🇨🇳

Shanghai, Shanghai, China

Shanghai General Hospital

🇨🇳

Shanghai, Shanghai, China

Tianjin Xiqing Hospital

🇨🇳

Tianjin, Tianjin, China

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

🇨🇳

Hangzhou, Zhejiang, China

Tianjin Third Central Hospital

🇨🇳

Tianjin, China

© Copyright 2025. All Rights Reserved by MedPath