Optimized Treatment and Regression of HBV-induced Early Cirrhosis

This study is currently recruiting participants.
Verified September 2013 by Beijing Friendship Hospital
Sponsor:
Collaborators:
Peking University People's Hospital
RenJi Hospital
Peking University
Shanghai Zhongshan Hospital
Fudan University
Shanghai First People's Hospital
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
the Fifth Hospital of Shijiazhuang
Affiliated Hospital of the Logistics University of the Chinese People's Armed Police Force
The First Affiliated Hospital of Shanxi Medical University
The Affiliated Hospital of Yanbian University
Information provided by (Responsible Party):
Hong You, Beijing Friendship Hospital
ClinicalTrials.gov Identifier:
NCT01938820
First received: September 5, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted

September 5, 2013
September 5, 2013
June 2013
June 2015   (final data collection date for primary outcome measure)
Regression of HBV-induced liver cirrhosis [ Time Frame: 1.5 to 2 years ] [ Designated as safety issue: No ]
Liver cirrhosis regression of 1 point by Ishak scoring system
Same as current
No Changes Posted
  • Child-Pugh score [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
    Child-Pugh score change after 1 and 2-year treatment
  • HBVDNA undetectable rate [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
    The HBVDNA undetectable rate after 1 and 2-year treatment.
  • Fibroscan value [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
    Fibroscan value change after 1 and 2-year treatment
  • Life Quality [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
    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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Cirrhosis
  • Drug: entecavir
  • Drug: Thymosin-α
  • 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 2015
June 2015   (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.
Both
18 Years to 65 Years
No
Contact: Hong You, Doctor 8610-63139019 youhong30@sina.com
Contact: Jidong Jia, Doctor 8610-63139816 jiamd@263.net
China
 
NCT01938820
2013ZX10002004-2
Yes
Hong You, Beijing Friendship Hospital
Beijing Friendship Hospital
  • Peking University People's Hospital
  • RenJi Hospital
  • Peking University
  • Shanghai Zhongshan Hospital
  • Fudan University
  • Shanghai First People's Hospital
  • 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
  • the Fifth Hospital of Shijiazhuang
  • Affiliated Hospital of the Logistics University of the Chinese People's Armed Police Force
  • 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
September 2013

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