Back to resultsOptimized Treatment and Regression of HBV-induced Early Cirrhosis
Primary Purpose
Liver Cirrhosis
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
entecavir
Thymosin-α
Sponsored by
About this trial
This is an interventional treatment trial for Liver Cirrhosis focused on measuring Hepatitis B, Liver Cirrhosis, Regression, Efficacy
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Beijing Ditan Hospital, Capital Medical University
- Peking University First Hospital
- Peking University People's Hospital
- 302 Military Hospital Of China
- Beijing Friendship Hospital, Capital Medical University
- Beijing Tiantan Hospital, Capital Medical University
- Beijing YouAn Hospital, Capital Medical University
- Peking Union Medical College Hospital
- Peking University
- Nanfang Hospital, Southern Medical University
- Shijiazhuang Fifth Hospital
- Tongji Hospital, Tongji Medical College, Huazhong University of Science ＆Technology
- The Affiliated Hospital of Yanbian University
- Renji Hospital, Shanghai Jiao Tong University, School of Medicine
- Huashan Hospital, FuDan University
- Zhongshan Hospital Fudan University
- Shanghai First People's Hospital
- Shanghai Public Health Clinical Center
- The First Hospital of Shanxi Medical University
- The Hospital Affiliated to Logistics University of Chinese People's Armed Police Force
- Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Entecavir Therapy
Entecavir plus Thymosin-α
Arm Description
Entecavir monotherapy: entecavir, 0.5mg, qd, oral, for 2 years.
entecavir plus Thymosin-α 1.6μg, Twice a week, ih, in the middle of 1 year.
Outcomes
Primary Outcome Measures
Regression of HBV-induced liver cirrhosis
Liver cirrhosis regression of 1 point by Ishak scoring system
Secondary Outcome Measures
Child-Pugh score
Child-Pugh score change after 1 and 2-year treatment
HBVDNA undetectable rate
The HBVDNA undetectable rate after 1 and 2-year treatment.
Fibroscan value
Fibroscan value change after 1 and 2-year treatment
Life Quality
Life quality change after 1 and 2-year treatment by SF-36 and EQ-5D questionaire
Full Information
NCT ID
NCT01938820
First Posted
September 5, 2013
Last Updated
July 26, 2018
Sponsor
Beijing Friendship Hospital
Collaborators
Peking University People's Hospital, RenJi Hospital, Peking University, Shanghai Zhongshan Hospital, Fudan University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, Nanfang Hospital, Southern Medical University, Sir Run Run Shaw Hospital, Beijing YouAn Hospital, Peking University First Hospital, Beijing 302 Hospital, Peking Union Medical College Hospital, Beijing Ditan Hospital, Beijing Tiantan Hospital, Huashan Hospital, Tongji Hospital, Tang-Du Hospital, Fifth Hospital of Shijiazhuang City, Logistics University of Chinese People's Armed Police Forces, The First Affiliated Hospital of Shanxi Medical University, The Affiliated Hospital of Yanbian University
1. Study Identification
Unique Protocol Identification Number
NCT01938820
Brief Title
Optimized Treatment and Regression of HBV-induced Early Cirrhosis
Official Title
Optimized Treatment and Regression of HBV-induced Early Cirrhosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital
Collaborators
Peking University People's Hospital, RenJi Hospital, Peking University, Shanghai Zhongshan Hospital, Fudan University, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, Nanfang Hospital, Southern Medical University, Sir Run Run Shaw Hospital, Beijing YouAn Hospital, Peking University First Hospital, Beijing 302 Hospital, Peking Union Medical College Hospital, Beijing Ditan Hospital, Beijing Tiantan Hospital, Huashan Hospital, Tongji Hospital, Tang-Du Hospital, Fifth Hospital of Shijiazhuang City, Logistics University of Chinese People's Armed Police Forces, The First Affiliated Hospital of Shanxi Medical University, The Affiliated Hospital of Yanbian University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Hepatitis B, Liver Cirrhosis, Regression, Efficacy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Entecavir Therapy
Arm Type
Active Comparator
Arm Description
Entecavir monotherapy:
entecavir, 0.5mg, qd, oral, for 2 years.
Arm Title
Entecavir plus Thymosin-α
Arm Type
Experimental
Arm Description
entecavir plus Thymosin-α 1.6μg, Twice a week, ih, in the middle of 1 year.
Intervention Type
Drug
Intervention Name(s)
entecavir
Other Intervention Name(s)
entecavir dispersible tablets
Intervention Description
anti-viral therapy
Intervention Type
Drug
Intervention Name(s)
Thymosin-α
Other Intervention Name(s)
Zadaxin
Intervention Description
antiviral and antifibrosis therapy
Primary Outcome Measure Information:
Title
Regression of HBV-induced liver cirrhosis
Description
Liver cirrhosis regression of 1 point by Ishak scoring system
Time Frame
1.5 to 2 years
Secondary Outcome Measure Information:
Title
Child-Pugh score
Description
Child-Pugh score change after 1 and 2-year treatment
Time Frame
1 year and 2 years
Title
HBVDNA undetectable rate
Description
The HBVDNA undetectable rate after 1 and 2-year treatment.
Time Frame
1 year and 2 years
Title
Fibroscan value
Description
Fibroscan value change after 1 and 2-year treatment
Time Frame
1 year and 2 years
Title
Life Quality
Description
Life quality change after 1 and 2-year treatment by SF-36 and EQ-5D questionaire
Time Frame
1 year and 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong You, Doctor
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Ditan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
302 Military Hospital Of China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing YouAn Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Peking University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100871
Country
China
Facility Name
Nanfang Hospital, Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Shijiazhuang Fifth Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050021
Country
China
Facility Name
Tongji Hospital, Tongji Medical College, Huazhong University of Science ＆Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
300030
Country
China
Facility Name
The Affiliated Hospital of Yanbian University
City
Yanji
State/Province
Jilin
ZIP/Postal Code
133000
Country
China
Facility Name
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Huashan Hospital, FuDan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai First People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201508
Country
China
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Facility Name
The Hospital Affiliated to Logistics University of Chinese People's Armed Police Force
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300162
Country
China
Facility Name
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310016
Country
China
12. IPD Sharing Statement
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Optimized Treatment and Regression of HBV-induced Early Cirrhosis
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