Optimized Treatment and Regression of HBV-induced Early 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
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
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:
NCT01938820
First received: September 5, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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 Intervention Phase
Liver Cirrhosis
Drug: entecavir
Drug: Thymosin-α
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimized Treatment and Regression of HBV-induced Early Cirrhosis

Resource links provided by NLM:


Further study details as provided by Beijing Friendship Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 200
Study Start Date: June 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Entecavir Therapy

Entecavir monotherapy:

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

Drug: entecavir
Experimental: Entecavir plus Thymosin-α
entecavir plus Thymosin-α 1.6μg, Twice a week, ih, in the middle of 1 year.
Drug: entecavir Drug: Thymosin-α

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01938820

Contacts
Contact: Hong You, Doctor 8610-63139019 youhong30@sina.com
Contact: Jidong Jia, Doctor 8610-63139816 jiamd@263.net

Locations
China, Beijing
Peking University Recruiting
Beijing, Beijing, China, 100871
Contact: Xueen Liu, Doctor    8601082802413    xueenliu@bjmu.edu.cn   
Principal Investigator: Xueen Liu, Doctor         
302 Military Hospital Of China Recruiting
Beijing, Beijing, China, 100039
Contact: Guofeng Chen, Doctor    13331119961    Bjchen302@yahoo.com.cn   
Principal Investigator: Guofeng Chen, Doctor         
Beijing Ditan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100015
Contact: Wen Xie, Doctor    13651113763    Xiewen6218@163.com   
Principal Investigator: Wen Xie, Doctor         
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Xiaoning Wu, Doctor    8610-63138665    wuxiaoningbs@126.com   
Principal Investigator: Hong You, Doctor         
Beijing Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Youqing Xu, Doctor    13552212981    youqingxu@hotmail.com   
Principal Investigator: Youqing Xu, Doctor         
302 Military Hospital Of China Recruiting
Beijing, Beijing, China, 100039
Contact: Hanwei Li, Doctor    13601068628    lhw@medmail.com.cn   
Principal Investigator: Hanwei Li, Doctor         
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Bo Feng, Doctor    13810254109    Xyfyfb_1@sina.com   
Principal Investigator: Bo Feng, Doctor         
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Xiaoyuan Xu, Doctor    13001185762    yangpin@public3.bta.net.cn   
Principal Investigator: Xiaoyuan Xu, Doctor         
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Xiaoqing Liu, Doctor    13911761571    liuxqpumch@hotmail.com   
Principal Investigator: Xiaoqing Liu, Doctor         
Beijing YouAn Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100069
Contact: Huiguo Ding, Doctor    13911683832    dinghuiguo@medmail.com.cn   
Principal Investigator: Huiguo Ding, Doctor         
China, Guangdong
Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Yongpeng Chen, doctor    13924203581    Cypmu@yahoo.com.cn   
Principal Investigator: Yongpeng Chen, Doctor         
China, Hebei
Shijiazhuang Fifth Hospital Recruiting
Shijiazhuang, Hebei, China, 050021
Contact: Huanwei Zheng, Doctor    13323119317    13323119317@189.cn   
Principal Investigator: Huanwei Zheng, Doctor         
China, Hubei
Tongji Hospital, Tongji Medical College, Huazhong University of Science &Technology Recruiting
Wuhan, Hubei, China, 300030
Contact: Tao Chen, Doctor    18971419301    corer0307@sina.com   
Principal Investigator: Tao Chen, Doctor         
China, Jilin
The Affiliated Hospital of Yanbian University Recruiting
Yanji, Jilin, China, 133000
Contact: Hongxin Pao, Doctor    15526770394    15526770394@163.com   
Principal Investigator: Hongxin Piao, Doctor         
China, Shanghai
Shanghai Public Health Clinical Center Recruiting
Shanghai, Shanghai, China, 201508
Contact: Jilin Cheng, Doctor    18916035612    jilincheng@gmail.com   
Principal Investigator: Jilin Cheng, Doctor         
Shanghai First People's Hospital Recruiting
Shanghai, Shanghai, China, 200080
Contact: Lungen Lu, Doctor    13381616206    Lungenlu1965@yahoo.com   
Principal Investigator: Lungen Lu, Doctor         
Renji Hospital, Shanghai Jiao Tong University, School of Medicine Recruiting
Shanghai, Shanghai, China, 200032
Contact: Yimin Mao, Doctor    13003175438    Mym11968@yahoo.com.cn   
Principal Investigator: Yimin Mao, Doctor         
Huashan Hospital, FuDan University Recruiting
Shanghai, Shanghai, China, 200040
Contact: Guangfeng Shi, Doctor    13817780666    Gfshi2005@163.com   
Principal Investigator: Guangfeng Shi, Doctor         
Zhongshan Hospital Fudan University Recruiting
Shanghai, Shanghai, China, 200040
Contact: Jiyao Wang, Doctor    13616014132    Wang.jiyao@zs-hospital.sh.cn   
Principal Investigator: Jiyao Wang, Doctor         
China, Shanxi
The First Hospital of Shanxi Medical University Recruiting
Taiyuan, Shanxi, China, 030001
Contact: Lijuan Huo, Doctor    13835107953    mymail5296@163.com   
Principal Investigator: Lijuan Huo, Doctor         
China, Tianjin
The Hospital Affiliated to Logistics University of Chinese People's Armed Police Force Recruiting
Tianjin, Tianjin, China, 300162
Contact: Hai Li, Doctor    15202265600    15202265600@163.com   
Principal Investigator: Hai Li, Doctor         
China, Zhejiang
Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University Recruiting
Hangzhou, Zhejiang, China, 310016
Contact: Xiaoming Yang, Doctor    13805737590    xmyang@uw.edu   
Principal Investigator: Xiaoming Yang, Doctor         
Sponsors and Collaborators
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
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
Principal Investigator: Hong You, Doctor Beijing Friendship Hospital
  More Information

No publications provided

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
Study First Received: September 5, 2013
Last Updated: September 5, 2013
Health Authority: China: Ministry of Science and Technology

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

Additional relevant MeSH terms:
Liver Cirrhosis
Digestive System Diseases
Liver Diseases
Entecavir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014