Optimized Treatment and Regression of HBV-induced Early Cirrhosis
1 other identifier
interventional
82
1 country
21
Brief Summary
Patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir for the first 0.5 year, entecavir plus thymosin for 1 year, entecavir for another additional 0.5 year. Patients will be assessed at baseline, at every six months for blood count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan. The second liver biopsy will be performed to evaluate regression rate of liver fibrosis 1.5 years after initial therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jun 2013
Longer than P75 for phase_4
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 5, 2013
CompletedFirst Posted
Study publicly available on registry
September 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedJuly 27, 2018
July 1, 2018
3.5 years
September 5, 2013
July 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Regression of HBV-induced liver cirrhosis
Liver cirrhosis regression of 1 point by Ishak scoring system
1.5 to 2 years
Secondary Outcomes (4)
Child-Pugh score
1 year and 2 years
HBVDNA undetectable rate
1 year and 2 years
Fibroscan value
1 year and 2 years
Life Quality
1 year and 2 years
Study Arms (2)
Entecavir Therapy
ACTIVE COMPARATOREntecavir monotherapy: entecavir, 0.5mg, qd, oral, for 2 years.
Entecavir plus Thymosin-α
EXPERIMENTALentecavir plus Thymosin-α 1.6μg, Twice a week, ih, in the middle of 1 year.
Interventions
anti-viral therapy
Eligibility Criteria
You may qualify if:
- Patients from age 18 to 65 years old;
- Male or female;
- Treatment-naive patients with chronic hepatitis B histologically confirmed of early cirrhosis S4 (similar to metavir F4, Ishak 5/6) who consent to undergo liver biopsy before and after treatment;
- Patients with HBeAg-positive, HBVDNA\>2×10\<3\>IU/ml or patients with HBeAg-negative, HBVDNA\>2×10\<2\> IU/ml；
- Agree to be followed up regularly;
- Signature of written informed consent.
You may not qualify if:
- Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma;
- Patients who are allergic to entecavir, thymosin or their components, and those considered not suitable for drugs used in this study;
- 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;
- Patients with baseline AFP level higher than 100 ng/ml and possible malignant lesion on image, or AFP level higher than 100 ng/ml for more than three months;
- Creatinine \>1.5×ULN;
- Patients with other uncured malignant tumors;
- Patients with severe diseases of heart, lung, kidney, brain, blood or other organs;
- Patients with any other reasons not suitable for the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Friendship Hospitallead
- Peking University People's Hospitalcollaborator
- RenJi Hospitalcollaborator
- Peking Universitycollaborator
- Shanghai Zhongshan Hospitalcollaborator
- Fudan Universitycollaborator
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicinecollaborator
- Shanghai Public Health Clinical Centercollaborator
- Nanfang Hospital, Southern Medical Universitycollaborator
- Sir Run Run Shaw Hospitalcollaborator
- Beijing YouAn Hospitalcollaborator
- Peking University First Hospitalcollaborator
- Beijing 302 Hospitalcollaborator
- Peking Union Medical College Hospitalcollaborator
- Beijing Ditan Hospitalcollaborator
- Beijing Tiantan Hospitalcollaborator
- Huashan Hospitalcollaborator
- Tongji Hospitalcollaborator
- Tang-Du Hospitalcollaborator
- Fifth Hospital of Shijiazhuang Citycollaborator
- Logistics University of Chinese People's Armed Police Forcescollaborator
- The First Affiliated Hospital of Shanxi Medical Universitycollaborator
- The Affiliated Hospital of Yanbian Universitycollaborator
Study Sites (21)
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100015, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peking University People's Hospital
Beijing, Beijing Municipality, 100034, China
302 Military Hospital Of China
Beijing, Beijing Municipality, 100039, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050, China
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
Peking University
Beijing, Beijing Municipality, 100871, China
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515, China
Shijiazhuang Fifth Hospital
Shijiazhuang, Hebei, 050021, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science ＆Technology
Wuhan, Hubei, 300030, China
The Affiliated Hospital of Yanbian University
Yanji, Jilin, 133000, China
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai Municipality, 200032, China
Huashan Hospital, FuDan University
Shanghai, Shanghai Municipality, 200040, China
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200040, China
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, 201508, China
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
The Hospital Affiliated to Logistics University of Chinese People's Armed Police Force
Tianjin, Tianjin Municipality, 300162, China
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310016, China
Related Publications (1)
Lu Z, Sun YM, Chen S, Meng T, Wang B, Zhou J, Wu X, Zhao X, Ou X, Kong YY, Jia J, Zhao X, You H. Multiple Low-Level Viraemia Suggest Hindered Liver Fibrosis Regression in Chronic Hepatitis B Patients During Antiviral Therapy. J Viral Hepat. 2024 Dec;31(12):898-902. doi: 10.1111/jvh.14012. Epub 2024 Oct 7.
PMID: 39373164DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong You, Doctor
Beijing Friendship Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice-Director of Liver Research Center
Study Record Dates
First Submitted
September 5, 2013
First Posted
September 10, 2013
Study Start
June 1, 2013
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
July 27, 2018
Record last verified: 2018-07