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
  Purpose

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;


Condition Intervention Phase
Liver Cirrhosis
Drug: Entecavir
Drug: Thymosin-α
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

Resource links provided by NLM:


Further study details as provided by Beijing Friendship Hospital:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 600
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, 0.5mg, qd, oral, for 2 years
Drug: Entecavir
Experimental: Entecavir plus thymosin therapy
Entecavir plus thymosin-α 1.6μg, Twice a week, ih, in the middle one 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 ;
  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.
  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: NCT01943617

Contacts
Contact: Hong You, Doctor 010-63139019 youhong30@sina.com
Contact: Jidong Jia, Doctor 010-63139816 jiamd@263.net

Locations
China, Beijing
Beijing Friendship Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Xiaoning Wu, Doctor    13439561979    wuxiaoningbs@126.com   
Principal Investigator: Hong You, Postdoctor         
Peking University People's Hospital Recruiting
Beijing, Beijing, China, 100050
Contact: Bo Feng, Doctor    13810254109    Xyfyfb_1@sina.com   
Principal Investigator: Bo Feng, Doctor         
PeKing University Recruiting
Beijing, Beijing, China, 100871
Contact: Xue'en Liu, Doctor    010-82802413    xueenliu@bjmu.edu.cn   
Principal Investigator: Xue'en 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         
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Xiaoyuan Xu, Doctor    13001185762    yangpin@public3.bta.net.cn   
Principal Investigator: Xiaoyuan Xu, 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         
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 Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Xiaoqing Liu, Doctor    13911761571    liuxqpumch@hotmail.com   
Principal Investigator: Xiaoqing Liu, 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 Tiantan Hospital, Capital Medical University Recruiting
Beijing, Beijing, China, 100050
Contact: Youqing Xu, Doctor    13552212981    youqingxu@hotmail.com   
Principal Investigator: Youqing Xu, Doctor         
China, Guangdong
NanfangHospital,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, 50021
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, Jiangsu
Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University Recruiting
Hangzhou, Jiangsu, China, 310016
Contact: Jihong Sun, Doctor    13957176538    braversun@sina.com   
Principal Investigator: Xiaoming Yang, Doctor         
China, Jilin
The Affiliated Hospital of Yanbian University Recruiting
Yanbian, Jilin, China, 133000
Contact: Hongxin Piao, Doctor    15526770394    15526770394@163.com   
Principal Investigator: Hongxin Piao, Doctor         
China, Shanghai
RenjiHospital,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         
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         
Shanghai First People's Hospital Recruiting
Shanghai, Shanghai, China, 200080
Contact: Lungen Lu, Doctor    13381616206    Lungenlu1965@yahoo.com   
Principal Investigator: Lungen Lu, Doctor         
Shanghai Public Health Clinical Center Recruiting
Shanghai, Shanghai, China, 201508
Contact: Jilin Cheng, Doctor    18916035612    jilincheng@gmail.com   
Principal Investigator: Jilin Cheng, Doctor         
Huashan Hospital FuDan University Recruiting
Shanghai, Shanghai, China, 200040
Contact: Guangfeng Shi, Doctor    13817780666    Gfshi2005@163.com   
Principal Investigator: Guangfeng Shi, Doctor         
China, Shanxi
The First Hospital of Shanxi Medical University Recruiting
Taiyuan, Shanxi, China, 30001
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         
Sponsors and Collaborators
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
Investigators
Principal Investigator: Hong You, Doctor Beijing Friendship Hospital
  More Information

No publications provided

Responsible Party: Hong You, Vice-Director Liver Research Centre, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT01943617     History of Changes
Other Study ID Numbers: 2013ZX10002004-3
Study First Received: September 5, 2013
Last Updated: September 12, 2013
Health Authority: China: Ministry of Science and Technology

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

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

ClinicalTrials.gov processed this record on September 15, 2014