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Optimized Treatment and Regression of HBV-induced Liver Fibrosis

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ClinicalTrials.gov Identifier: NCT01938781
Recruitment Status : Recruiting
First Posted : September 10, 2013
Last Update Posted : January 14, 2016
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 Rate of HBV-induced Liver Fibrosis [ Time Frame: 1.5 to 2 years ]
Fibrosis regression of 1 point by Ishak scoring system
Same as current
Complete list of historical versions of study NCT01938781 on ClinicalTrials.gov Archive Site
  • HBVDNA undetectable rate [ Time Frame: 1 year and 2 years ]
    The HBVDNA undetectable rate after 1 year and 2-year treatment
  • Fibroscan scores [ Time Frame: 1 year and 2 years ]
    Fibroscan scores after 1 and 2-year treatment
  • Life Quality [ Time Frame: 1 year and 2 years ]
    Life quality after 1 and 2-year treatment by SF-36 and EQ-5D questionaire
  • Incidence of drug resistance [ Time Frame: 1 year and 2 years ]
    Incidence of drug resistance after 1 and 2-year treatment
Same as current
Not Provided
Not Provided
Optimized Treatment and Regression of HBV-induced Liver Fibrosis
Optimized Treatment and Regression of HBV-induced Liver Fibrosis
Patients with chronic hepatitis B histologically confirmed of liver fibrosis S2/S3 (similar to metavir F2/F3, Ishak 2/3/4) 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 pegylated interferon (peg-IFN) 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, thyroid function, 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
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Liver Fibrosis
  • Drug: entecavir
    antiviral therapy
    Other Name: entecavir dispersible tablets
  • Drug: Peg-IFN
    antiviral and antifibrosis therapy
    Other Name: Pegasys
  • Active Comparator: Entecavir monotherapy
    entecavir, 0.5mg, qd, oral, for 2 years.
    Intervention: Drug: entecavir
  • Experimental: Entecavir plus peg-IFN Therapy
    entecavir combined peg-IFN in the middle 1 year.
    • Drug: entecavir
    • Drug: Peg-IFN
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 2016   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Ages from 18 to 65 years old;
  2. Male or female;
  3. Treatment-naive patients with chronic HBV-induced fibrosis S2/S3 (similar to F2/F3, Ishak 2/3/4), who consent to undergo liver biopsy before and after treatment;
  4. Patients with HBeAg-positive, HBVDNA>2×10<4> IU/ml or with HBeAg-negative, HBVDNA>2×10<3> IU/ml;
  5. Agree to be follow-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, interferon, or their components, and those considered not suitable for medications used in this study;
  3. Patients coinfection with HCV or HIV, 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 continuous 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 severe neurological or psychological disease (e.g. epilepsy, depression, mania and schizophrenia);
  9. Patients with poorly controlled diabetes, hypertension or thyroid disease;
  10. 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 8610-63139019 youhong30@sina.com
Contact: Jidong Jia, Doctor 8610-63139816 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