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Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

Primary Purpose

Liver Cirrhosis

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Entecavir
Thymosin-α
Sponsored by
Beijing Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhosis focused on measuring Liver Cirrhosis, Hepatitis B, Compensation, Efficacy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beijing Ditan Hospital, Capital Medical University
  • Peking University First Hospital
  • 302 Military Hospital Of China
  • Beijing Friendship Hospital, Capital Medical University
  • Beijing Tiantan Hospital, Capital Medical University
  • Peking University People's Hospital
  • Beijing YouAn Hospital, Capital Medical University
  • Peking Union Medical College Hospital
  • PeKing University
  • NanfangHospital,Southern Medical University
  • Shijiazhuang Fifth Hospital
  • Tongji Hospital, Tongji Medical College ,Huazhong University of Science ＆Technology
  • Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University
  • The Affiliated Hospital of Yanbian University
  • RenjiHospital,Shanghai Jiao Tong University,School of Medicine
  • Huashan Hospital FuDan University
  • Zhongshan Hospital Fudan University
  • Shanghai First People's Hospital
  • Shanghai Public Health Clinical Center
  • The First Hospital of Shanxi Medical University
  • The Hospital Affiliated to Logistics University of Chinese People's Armed Police Force

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Entecavir Therapy

Entecavir plus thymosin therapy

Arm Description

Entecavir, 0.5mg, qd, oral, for 2 years

Entecavir plus thymosin-α 1.6μg, Twice a week, ih, in the middle one year

Outcomes

Primary Outcome Measures

Decompensated rate of Liver Cirrhosis after 2 years treatment
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
The progress of Child-Pugh and MELD scores after 1 and 2-year treatment
The HBV DNA undetectable rate
The HBV DNA undetectable rate after 1 and 2-year treatment
Liver stiffness measurement
Liver stiffness measurement change after 1 and 2-year treatment.
Quality of Life
Quality of life after 1 and 2-year treatment by SF-36 and EQ-5D questionares

Full Information

First Posted
September 5, 2013
Last Updated
July 26, 2018
Sponsor
Beijing Friendship Hospital
Collaborators
Peking University People's Hospital, RenJi Hospital, Peking University, Shanghai Zhongshan Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, Nanfang Hospital, 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
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1. Study Identification

Unique Protocol Identification Number
NCT01943617
Brief Title
Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis
Official Title
Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Friendship Hospital
Collaborators
Peking University People's Hospital, RenJi Hospital, Peking University, Shanghai Zhongshan Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Public Health Clinical Center, Nanfang Hospital, 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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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;

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhosis
Keywords
Liver Cirrhosis, Hepatitis B, Compensation, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
606 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Entecavir Therapy
Arm Type
Active Comparator
Arm Description
Entecavir, 0.5mg, qd, oral, for 2 years
Arm Title
Entecavir plus thymosin therapy
Arm Type
Experimental
Arm Description
Entecavir plus thymosin-α 1.6μg, Twice a week, ih, in the middle one year
Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
Entecavir dispersible tablets
Intervention Description
anti-viral therapy
Intervention Type
Drug
Intervention Name(s)
Thymosin-α
Other Intervention Name(s)
Zadaxin
Intervention Description
anti-viral and antitherapy
Primary Outcome Measure Information:
Title
Decompensated rate of Liver Cirrhosis after 2 years treatment
Description
Decompensated rate of Liver Cirrhosis (ascites, hepatic encephalopathy, esophageal varices bleeding and Hepatocellular Carcinoma) after 2 years treatment.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Child-Pugh and MELD scores
Description
The progress of Child-Pugh and MELD scores after 1 and 2-year treatment
Time Frame
1 and 2-year
Title
The HBV DNA undetectable rate
Description
The HBV DNA undetectable rate after 1 and 2-year treatment
Time Frame
1 and 2-year
Title
Liver stiffness measurement
Description
Liver stiffness measurement change after 1 and 2-year treatment.
Time Frame
1 and 2-year
Title
Quality of Life
Description
Quality of life after 1 and 2-year treatment by SF-36 and EQ-5D questionares
Time Frame
1 and 2-year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients from age 18 to 65 years ; Male or female; Treatment-naive patients of clinically diagnosed as HBV-induced compensated cirrhosis(meet one of the following two criterions); endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension 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) HBeAg-positive, HBVDNA > 2×10<3> IU/ml or with HBeAg-negative patients, HBVDNA > 2×10<2> IU/ml; Agree to be followed up regularly; Signature of written inform consent. Exclusion Criteria: Patients with decompensated cirrhosis: including ascites, hepatic encephalopathy, esophageal varices bleeding or other complications of decompensated cirrhosis or hepatocelluar carcinoma; Patients who are allergic to entecavir, thymosin or their components, and those considered not suitable for medicine in this study; 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; 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; Creatinine > 1.5×ULN; Patients with other uncured malignant tumors; Patients with severe diseases of heart, lung, kidney, brain, blood system or other organs; Patients with any other reasons not suitable for the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hong You, Doctor
Organizational Affiliation
Beijing Friendship Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Ditan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
302 Military Hospital Of China
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Beijing Friendship Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing Tiantan Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Beijing YouAn Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
PeKing University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100871
Country
China
Facility Name
NanfangHospital,Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510515
Country
China
Facility Name
Shijiazhuang Fifth Hospital
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
50021
Country
China
Facility Name
Tongji Hospital, Tongji Medical College ,Huazhong University of Science ＆Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
300030
Country
China
Facility Name
Sir Run Run Shaw Hospital,School of Medicine,Zhejiang University
City
Hangzhou
State/Province
Jiangsu
ZIP/Postal Code
310016
Country
China
Facility Name
The Affiliated Hospital of Yanbian University
City
Yanbian
State/Province
Jilin
ZIP/Postal Code
133000
Country
China
Facility Name
RenjiHospital,Shanghai Jiao Tong University,School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Name
Huashan Hospital FuDan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Zhongshan Hospital Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai First People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201508
Country
China
Facility Name
The First Hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
30001
Country
China
Facility Name
The Hospital Affiliated to Logistics University of Chinese People's Armed Police Force
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300162
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34843068
Citation
Wu X, Hong J, Zhou J, Sun Y, Li L, Xie W, Piao H, Xu X, Jiang W, Feng B, Chen Y, Xu M, Cheng J, Meng T, Wang B, Chen S, Kong Y, Ou X, You H, Jia J. Health-related quality of life improves after entecavir treatment in patients with compensated HBV cirrhosis. Hepatol Int. 2021 Dec;15(6):1318-1327. doi: 10.1007/s12072-021-10240-4. Epub 2021 Nov 29.
Results Reference
derived
PubMed Identifier
33460002
Citation
Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J. Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy. Hepatol Int. 2021 Feb;15(1):82-92. doi: 10.1007/s12072-020-10114-1. Epub 2021 Jan 18.
Results Reference
derived

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Optimized Treatment and Regression of HBV-induced Compensated Liver Cirrhosis

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