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Optimized Treatment and Regression of HBV-induced Early Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01938820
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : July 27, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Hong You, Beijing Friendship Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Drug: entecavir Drug: Thymosin-α Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimized Treatment and Regression of HBV-induced Early Cirrhosis
Study Start Date : June 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
Drug Information available for: Entecavir

Arm Intervention/treatment
Active Comparator: Entecavir Therapy

Entecavir monotherapy:

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

Drug: entecavir
anti-viral therapy
Other Name: entecavir dispersible tablets

Experimental: Entecavir plus Thymosin-α
entecavir plus Thymosin-α 1.6μg, Twice a week, ih, in the middle of 1 year.
Drug: entecavir
anti-viral therapy
Other Name: entecavir dispersible tablets

Drug: Thymosin-α
antiviral and antifibrosis therapy
Other Name: Zadaxin




Primary Outcome Measures :
  1. Regression of HBV-induced liver cirrhosis [ Time Frame: 1.5 to 2 years ]
    Liver cirrhosis regression of 1 point by Ishak scoring system


Secondary Outcome Measures :
  1. Child-Pugh score [ Time Frame: 1 year and 2 years ]
    Child-Pugh score change after 1 and 2-year treatment

  2. HBVDNA undetectable rate [ Time Frame: 1 year and 2 years ]
    The HBVDNA undetectable rate after 1 and 2-year treatment.

  3. Fibroscan value [ Time Frame: 1 year and 2 years ]
    Fibroscan value change after 1 and 2-year treatment

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938820


Locations
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China, Beijing
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing, China, 100015
Peking University First Hospital
Beijing, Beijing, China, 100034
Peking University People's Hospital
Beijing, Beijing, China, 100034
302 Military Hospital Of China
Beijing, Beijing, China, 100039
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing, China, 100050
Beijing YouAn Hospital, Capital Medical University
Beijing, Beijing, China, 100069
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
Peking University
Beijing, Beijing, China, 100871
China, Guangdong
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515
China, Hebei
Shijiazhuang Fifth Hospital
Shijiazhuang, Hebei, China, 050021
China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science &Technology
Wuhan, Hubei, China, 300030
China, Jilin
The Affiliated Hospital of Yanbian University
Yanji, Jilin, China, 133000
China, Shanghai
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai, China, 200032
Huashan Hospital, FuDan University
Shanghai, Shanghai, China, 200040
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China, 200040
Shanghai First People's Hospital
Shanghai, Shanghai, China, 200080
Shanghai Public Health Clinical Center
Shanghai, Shanghai, China, 201508
China, Shanxi
The First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
China, Tianjin
The Hospital Affiliated to Logistics University of Chinese People's Armed Police Force
Tianjin, Tianjin, China, 300162
China, Zhejiang
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310016
Sponsors and Collaborators
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
Investigators
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Principal Investigator: Hong You, Doctor Beijing Friendship Hospital

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Responsible Party: Hong You, Vice-Director of Liver Research Center, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT01938820     History of Changes
Other Study ID Numbers: 2013ZX10002004-2
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018

Keywords provided by Hong You, Beijing Friendship Hospital:
Hepatitis B
Liver Cirrhosis
Regression
Efficacy

Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Entecavir
Antiviral Agents
Anti-Infective Agents