Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Beijing Friendship Hospital
Sponsor:
Collaborators:
Peking University People's Hospital
RenJi Hospital
Peking University
Shanghai Zhongshan Hospital
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
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
Information provided by (Responsible Party):
Hong You, Beijing Friendship Hospital
ClinicalTrials.gov Identifier:
NCT01943617
First received: September 5, 2013
Last updated: September 12, 2013
Last verified: September 2013

September 5, 2013
September 12, 2013
June 2013
June 2015   (final data collection date for primary outcome measure)
Decompensated rate of Liver Cirrhosis after 2 years treatment [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The HBV DNA undetectable rate after 1 and 2-year treatment
  • Liver stiffness measurement [ Time Frame: 1 and 2-year ] [ Designated as safety issue: No ]
    Liver stiffness measurement change after 1 and 2-year treatment.
  • Quality of Life [ Time Frame: 1 and 2-year ] [ Designated as safety issue: No ]
    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
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Cirrhosis
  • Drug: Entecavir
  • Drug: Thymosin-α
  • 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
    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
600
December 2015
June 2015   (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.
Both
18 Years to 65 Years
No
Contact: Hong You, Doctor 010-63139019 youhong30@sina.com
Contact: Jidong Jia, Doctor 010-63139816 jiamd@263.net
China
 
NCT01943617
2013ZX10002004-3
Yes
Hong You, Beijing Friendship Hospital
Beijing Friendship Hospital
  • Peking University People's Hospital
  • RenJi Hospital
  • Peking University
  • Shanghai Zhongshan Hospital
  • 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
  • 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
September 2013

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