Optimized Treatment and Regression of HBV-induced Liver Fibrosis

This study is ongoing, but not recruiting participants.
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:
NCT01938781
First received: September 5, 2013
Last updated: July 27, 2015
Last verified: July 2015
  Purpose

Patients with chronic hepatitis B histologically confirmed of liver fibrosis S2/S3 (similar to metavir F2/F3, Ishak 2/3/4) 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 pegylated interferon (peg-IFN) 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, thyroid function, 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 Fibrosis
Drug: entecavir
Drug: Peg-IFN
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Beijing Friendship Hospital:

Primary Outcome Measures:
  • Regression Rate of HBV-induced Liver Fibrosis [ Time Frame: 1.5 to 2 years ] [ Designated as safety issue: No ]
    Fibrosis regression of 1 point by Ishak scoring system


Secondary Outcome Measures:
  • HBVDNA undetectable rate [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
    The HBVDNA undetectable rate after 1 year and 2-year treatment

  • Fibroscan scores [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
    Fibroscan scores after 1 and 2-year treatment

  • Life Quality [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
    Life quality after 1 and 2-year treatment by SF-36 and EQ-5D questionaire

  • Incidence of drug resistance [ Time Frame: 1 year and 2 years ] [ Designated as safety issue: No ]
    Incidence of drug resistance after 1 and 2-year treatment


Estimated Enrollment: 400
Study Start Date: June 2013
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Entecavir monotherapy
entecavir, 0.5mg, qd, oral, for 2 years.
Drug: entecavir
antiviral therapy
Other Name: entecavir dispersible tablets
Experimental: Entecavir plus peg-IFN Therapy
entecavir combined peg-IFN in the middle 1 year.
Drug: entecavir
antiviral therapy
Other Name: entecavir dispersible tablets
Drug: Peg-IFN
antiviral and antifibrosis therapy
Other Name: Pegasys

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Ages from 18 to 65 years old;
  2. Male or female;
  3. Treatment-naive patients with chronic HBV-induced fibrosis S2/S3 (similar to F2/F3, Ishak 2/3/4), who consent to undergo liver biopsy before and after treatment;
  4. Patients with HBeAg-positive, HBVDNA>2×10<4> IU/ml or with HBeAg-negative, HBVDNA>2×10<3> IU/ml;
  5. Agree to be follow-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, interferon, or their components, and those considered not suitable for medications used in this study;
  3. Patients coinfection with HCV or HIV, 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 continuous 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 severe neurological or psychological disease (e.g. epilepsy, depression, mania and schizophrenia);
  9. Patients with poorly controlled diabetes, hypertension or thyroid disease;
  10. 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: NCT01938781

Locations
China, Beijing
Peking University People's Hospital
Beijing, Beijing, China, 100034
Beijing Ditan Hospital, Capital Medical University
Beijing, Beijing, China, 100015
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 Uiversity
Beijing, Beijing, China, 100871
Peking Union Medical College Hospital
Beijing, Beijing, China, 100730
302 Military Hospital Of China
Beijing, Beijing, China, 100039
Peking University First Hospital
Beijing, Beijing, China, 100034
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
Huashan Hospital FuDan University
Shanghai, Shanghai, China, 200040
Renji Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai, Shanghai, China, 200032
Shanghai First People's Hospital
Shanghai, Shanghai, China, 200080
Shanghai Public Health Clinical Center
Shanghai, Shanghai, China, 201508
Zhongshan Hospital Fudan University
Shanghai, Shanghai, China, 200040
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
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: NCT01938781     History of Changes
Other Study ID Numbers: 2013ZX10002004-1
Study First Received: September 5, 2013
Last Updated: July 27, 2015
Health Authority: China: Ministry of Science and Technology

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

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

ClinicalTrials.gov processed this record on August 30, 2015