Optimized Treatment and Regression of HBV-induced Early Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

Optimized Treatment and Regression of HBV-induced Early Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01938820
• Other study ID #: 2013ZX10002004-2
• Status: Completed
• Phase: Phase 4
• Start date: June 2013
• Est. completion date: December 2016

Study information

• Verified date: July 2018
• Source: Beijing Friendship Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Patients from age 18 to 65 years old;

2. Male or female;

3. 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;

4. Patients with HBeAg-positive, HBVDNA>2×10<3>IU/ml or patients with HBeAg-negative, HBVDNA>2×10<2> IU/ml;

5. Agree to be followed up regularly;

6. Signature of written informed 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 drugs used 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 100 ng/ml and possible malignant lesion on image, or AFP level higher than 100 ng/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 or other organs;

8. Patients with any other reasons not suitable for the study.

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis

Intervention

Drug:
• entecavir
anti-viral therapy
• Thymosin-a
antiviral and antifibrosis therapy

Locations

Country	Name	City	State
China	302 Military Hospital Of China	Beijing	Beijing
China	Beijing Ditan Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Friendship Hospital, Capital Medical University	Beijing	Beijing
China	Beijing Tiantan Hospital, Capital Medical University	Beijing	Beijing
China	Beijing YouAn Hospital, Capital Medical University	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	Peking University	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Huashan Hospital, FuDan University	Shanghai	Shanghai
China	Renji Hospital, Shanghai Jiao Tong University, School of Medicine	Shanghai	Shanghai
China	Shanghai First People's Hospital	Shanghai	Shanghai
China	Shanghai Public Health Clinical Center	Shanghai	Shanghai
China	Zhongshan Hospital Fudan University	Shanghai	Shanghai
China	Shijiazhuang Fifth Hospital	Shijiazhuang	Hebei
China	The First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	The Hospital Affiliated to Logistics University of Chinese People's Armed Police Force	Tianjin	Tianjin
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science &Technology	Wuhan	Hubei
China	The Affiliated Hospital of Yanbian University	Yanji	Jilin

Sponsors (23)

Lead Sponsor

Collaborator

Beijing Friendship Hospital

Beijing 302 Hospital, Beijing Ditan Hospital, Beijing Tiantan Hospital, Beijing YouAn Hospital, Fifth Hospital of Shijiazhuang City, Fudan University, Huashan Hospital, Logistics University of Chinese People's Armed Police Forces, Nanfang Hospital of Southern Medical University, Peking Union Medical College Hospital, Peking University, Peking University First Hospital, Peking University People's Hospital, RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, Shanghai Zhongshan Hospital, Sir Run Run Shaw Hospital, Tang-Du Hospital, The Affiliated Hospital of Yanbian University, The First Affiliated Hospital of Shanxi Medical University, Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regression of HBV-induced liver cirrhosis	Liver cirrhosis regression of 1 point by Ishak scoring system	1.5 to 2 years
Secondary	Child-Pugh score	Child-Pugh score change after 1 and 2-year treatment	1 year and 2 years
Secondary	HBVDNA undetectable rate	The HBVDNA undetectable rate after 1 and 2-year treatment.	1 year and 2 years
Secondary	Fibroscan value	Fibroscan value change after 1 and 2-year treatment	1 year and 2 years
Secondary	Life Quality	Life quality change after 1 and 2-year treatment by SF-36 and EQ-5D questionaire	1 year and 2 years