Effect of Entecavir Treatment on Regression and Disease Outcome in HBV-induced Liver Fibrosis and Cirrhosis Patients
- 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
- Subjects who completed the 2 years of entecavir-based therapy in Regress study; Subjects who are willing to participate the extension study.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment group Entecavir entecavir oral,0.5mg daily for 8 years
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Aminotransferase response year 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 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
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
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
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