Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01943617
• Other study ID #: 2013ZX10002004-3
• 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

Six hundreds patients with chronic hepatitis B clinically diagnosed as compensated liver cirrhosis are randomly assigned in a 1:1 ratio. One arm is entecavir alone for 2 years; the other is entecavir alone for the first 0.5 year, entecavir plus thymosin-α for 1 year, entecavir for another additional 0.5 year.Patients will be assessed at baseline, at every six months for blood cell count, liver function test, HBVDNA, AFP, prothrombin time, liver ultrasonography, and Fibroscan;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 606
• 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 ;

2. Male or female;

3. Treatment-naive patients of clinically diagnosed as HBV-induced compensated cirrhosis(meet one of the following two criterions);

1. endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension

2. if no endoscopy,should meet two of the four Criterias:

• Imaging (US, CT or MRI, et al) showing Surface nodularity: Echogenecity

• Platelet (PLT) < 100×10 < 9 >/L , no other interpretation

• Albumin (ALB) < 35.0 g/L, or International Standard Value (INR) > 1.3 (Prothrombin Time (PT) prolonged > 3s), or Cholinesterase (CHE) decrease

• Liver stiffness measurement value > 12.4 kpa (ALT<5×ULN)

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

5. Agree to be followed up regularly;

6. Signature of written inform 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 medicine 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 100ng/ml and possible malignant lesion on image, or AFP level higher than 100ng/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 system 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
anti-viral and antitherapy

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	NanfangHospital,Southern Medical University	Guangzhou	Guangdong
China	Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University	Hangzhou	Jiangsu
China	Huashan Hospital FuDan University	Shanghai	Shanghai
China	RenjiHospital,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	Yanbian	Jilin

Sponsors (22)

Lead Sponsor

Collaborator

Beijing Friendship Hospital

Beijing 302 Hospital, Beijing Ditan Hospital, Beijing Tiantan Hospital, Beijing YouAn Hospital, Fifth Hospital of Shijiazhuang City, 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	Decompensated rate of Liver Cirrhosis after 2 years treatment	Decompensated rate of Liver Cirrhosis (ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) after 2 years treatment.	2 years
Secondary	Child-Pugh and MELD scores	The progress of Child-Pugh and MELD scores after 1 and 2-year treatment	1 and 2-year
Secondary	The HBV DNA undetectable rate	The HBV DNA undetectable rate after 1 and 2-year treatment	1 and 2-year
Secondary	Liver stiffness measurement	Liver stiffness measurement change after 1 and 2-year treatment.	1 and 2-year
Secondary	Quality of Life	Quality of life after 1 and 2-year treatment by SF-36 and EQ-5D questionares	1 and 2-year