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Optimized Treatment and Regression of HBV-induced Liver Fibrosis

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:
NCT01938781
First received: September 5, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted

September 5, 2013
September 5, 2013
June 2013
June 2015   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Optimized Treatment and Regression of HBV-induced Liver Fibrosis
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver Fibrosis
  • Drug: entecavir
  • Drug: peg-IFN
  • Active Comparator: Entecavir monotherapy
    entecavir, 0.5mg, qd, oral, for 2 years.
    Intervention: Drug: entecavir
  • Experimental: Entecavir plus peg-IFN Therapy
    entecavir combined peg-IFN in the middle 1 year.
    Interventions:
    • Drug: entecavir
    • Drug: peg-IFN
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
December 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact: Hong You, Doctor 8610-63139019 youhong30@sina.com
Contact: Jidong Jia, Doctor 8610-63139816 jiamd@263.net
China
 
NCT01938781
2013ZX10002004-1
Yes
Hong You, Beijing Friendship Hospital
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
Principal Investigator: Hong You, Doctor Beijing Friendship Hospital
Beijing Friendship Hospital
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP