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Completed

NCT Number: NCT01938781

Optimized Treatment and Regression of HBV-induced Liver Fibrosis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

302 Military Hospital Of China, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ages from 18 to 65 years old;
  • Male or female;
  • 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;
  • Patients with HBeAg-positive, HBVDNA>2×10<4> IU/ml or with HBeAg-negative, HBVDNA>2×10<3> IU/ml;
  • Agree to be follow-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, interferon, or their components, and those considered not suitable for medications used in this study;
  • 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;
  • 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;
  • 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 severe neurological or psychological disease (e.g. epilepsy, depression, mania and schizophrenia);
  • Patients with poorly controlled diabetes, hypertension or thyroid disease;
  • Patients with any other reasons not suitable for the study.

Treatment and study plan

Entecavir

Drug

antiviral therapy

Other names: entecavir dispersible tablets

Peg-IFN

Drug

antiviral and antifibrosis therapy

Other names: Pegasys

Primary outcomes

  1. Regression Rate of HBV-induced Liver Fibrosis

    Time frame: 1.5 to 2 years

    Fibrosis regression of 1 point by Ishak scoring system

Secondary outcomes

  1. HBVDNA undetectable rate

    Time frame: 1 year and 2 years

    The HBVDNA undetectable rate after 1 year and 2-year treatment

  2. Fibroscan scores

    Time frame: 1 year and 2 years

    Fibroscan scores after 1 and 2-year treatment

  3. Life Quality

    Time frame: 1 year and 2 years

    Life quality after 1 and 2-year treatment by SF-36 and EQ-5D questionaire

  4. Incidence of drug resistance

    Time frame: 1 year and 2 years

    Incidence of drug resistance after 1 and 2-year treatment

Sponsors and collaborators

Lead sponsor

Beijing Friendship Hospital

Other

Collaborators

  • Beijing 302 Hospital
  • Beijing Ditan Hospital
  • Beijing Tiantan Hospital
  • Beijing YouAn Hospital
  • Fifth Hospital of Shijiazhuang City
  • Huashan Hospital
  • Logistics University of Chinese People's Armed Police Forces
  • Nanfang Hospital, Southern Medical University
  • Peking Union Medical College Hospital
  • Peking University
  • Peking University First Hospital
  • Peking University People's Hospital
  • RenJi Hospital
  • Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
  • Shanghai Public Health Clinical Center
  • Shanghai Zhongshan Hospital
  • Sir Run Run Shaw Hospital
  • Tang-Du Hospital
  • The Affiliated Hospital of Yanbian University
  • The First Affiliated Hospital of Shanxi Medical University
  • Tongji Hospital

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 10, 2013
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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