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Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

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ClinicalTrials.gov Identifier: NCT01943617
Recruitment Status : Recruiting
First Posted : September 17, 2013
Last Update Posted : January 14, 2016
Information provided by (Responsible Party):

September 5, 2013
September 17, 2013
January 14, 2016
June 2013
December 2018   (Final data collection date for primary outcome measure)
Decompensated rate of Liver Cirrhosis after 2 years treatment [ Time Frame: 2 years ]
Decompensated rate of Liver Cirrhosis (ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) after 2 years treatment.
Same as current
Complete list of historical versions of study NCT01943617 on ClinicalTrials.gov Archive Site
  • Child-Pugh and MELD scores [ Time Frame: 1 and 2-year ]
    The progress of Child-Pugh and MELD scores after 1 and 2-year treatment
  • The HBV DNA undetectable rate [ Time Frame: 1 and 2-year ]
    The HBV DNA undetectable rate after 1 and 2-year treatment
  • Liver stiffness measurement [ Time Frame: 1 and 2-year ]
    Liver stiffness measurement change after 1 and 2-year treatment.
  • Quality of Life [ Time Frame: 1 and 2-year ]
    Quality of life after 1 and 2-year treatment by SF-36 and EQ-5D questionares
Same as current
Not Provided
Not Provided
Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis
Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis
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;
Not Provided
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
    anti-viral and antitherapy
    Other Name: Zadaxin
  • Active Comparator: Entecavir Therapy
    Entecavir, 0.5mg, qd, oral, for 2 years
    Intervention: Drug: Entecavir
  • Experimental: Entecavir plus thymosin therapy
    Entecavir plus thymosin-α 1.6μg, Twice a week, ih, in the middle one year
    • 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.
December 2018
December 2018   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Contact: Hong You, Doctor 010-63139019 youhong30@sina.com
Contact: Jidong Jia, Doctor 010-63139816 jiamd@263.net
Not Provided
Not Provided
Hong You, Beijing Friendship Hospital
Beijing Friendship Hospital
  • Peking University People's Hospital
  • RenJi Hospital
  • Peking University
  • Shanghai Zhongshan Hospital
  • 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