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Optimized Treatment and Regression of HBV-induced Early Cirrhosis

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ClinicalTrials.gov Identifier: NCT01938820
Recruitment Status : Recruiting
First Posted : September 10, 2013
Last Update Posted : January 14, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

September 5, 2013
September 10, 2013
January 14, 2016
June 2013
December 2016   (Final data collection date for primary outcome measure)
Regression of HBV-induced liver cirrhosis [ Time Frame: 1.5 to 2 years ]
Liver cirrhosis regression of 1 point by Ishak scoring system
Same as current
Complete list of historical versions of study NCT01938820 on ClinicalTrials.gov Archive Site
  • Child-Pugh score [ Time Frame: 1 year and 2 years ]
    Child-Pugh score change after 1 and 2-year treatment
  • HBVDNA undetectable rate [ Time Frame: 1 year and 2 years ]
    The HBVDNA undetectable rate after 1 and 2-year treatment.
  • Fibroscan value [ Time Frame: 1 year and 2 years ]
    Fibroscan value change after 1 and 2-year treatment
  • Life Quality [ Time Frame: 1 year and 2 years ]
    Life quality change after 1 and 2-year treatment by SF-36 and EQ-5D questionaire
Same as current
Not Provided
Not Provided
 
Optimized Treatment and Regression of HBV-induced Early Cirrhosis
Optimized Treatment and Regression of HBV-induced Early Cirrhosis
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Liver Cirrhosis
  • Drug: entecavir
    anti-viral therapy
    Other Name: entecavir dispersible tablets
  • Drug: Thymosin-α
    antiviral and antifibrosis therapy
    Other Name: Zadaxin
  • Active Comparator: Entecavir Therapy

    Entecavir monotherapy:

    entecavir, 0.5mg, qd, oral, for 2 years.

    Intervention: Drug: entecavir
  • Experimental: Entecavir plus Thymosin-α
    entecavir plus Thymosin-α 1.6μg, Twice a week, ih, in the middle of 1 year.
    Interventions:
    • Drug: entecavir
    • Drug: Thymosin-α
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
December 2018
December 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact: Hong You, Doctor 8610-63139019 youhong30@sina.com
Contact: Jidong Jia, Doctor 8610-63139816 jiamd@263.net
China
 
 
NCT01938820
2013ZX10002004-2
Yes
Not Provided
Not Provided
Hong You, Beijing Friendship Hospital
Beijing Friendship Hospital
  • 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 of 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
Principal Investigator: Hong You, Doctor Beijing Friendship Hospital
Beijing Friendship Hospital
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP