Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 1 of 1 for:    NCT01148576
Previous Study | Return to List | Next Study

Influence of Hepatic Steatosis on the Therapeutic Effect of Entecavir in Chronic Hepatitis B Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Zhejiang University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Zhejiang University
ClinicalTrials.gov Identifier:
NCT01148576
First received: June 17, 2010
Last updated: June 21, 2010
Last verified: June 2010

June 17, 2010
June 21, 2010
June 2010
December 2011   (final data collection date for primary outcome measure)
Differences in the anti-viral effect of entecavir among CHB patients and CHB + hepatic steatosis patients who received different drugs [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The common measurement includes serum biochemistry markers (ALT, AST, GGT, CRP, PT, APTT, AMA, UA, Chol, TG, TB, DB, ALP, fasting glucose, insulin, et al), virus markers (HBs-Ag, Hbe-Ag, anti-HBc-Ab, HBV genotype, HBV- DNA copy, YMDD variation, et al), Liver CT scan or ultrasound (steatosis degree and fibrosis and changes in the histological features of liver biopsy(steatosis degree, inflammation and fibrosis).
Same as current
Complete list of historical versions of study NCT01148576 on ClinicalTrials.gov Archive Site
  • Differences in the sustained response rate to entecavir among CHB patients and CHB + hepatic steatosis patients who received different drugs and obtained anti-virus effect after 1 year treatment. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    The common measurement includes serum biochemistry markers (ALT, AST, GGT, CRP, PT, APTT, AMA, UA, Chol, TG, TB, DB, ALP, fasting glucose, insulin, et al), virus markers (HBs-Ag, Hbe-Ag, anti-HBc-Ab, HBV genotype, HBV- DNA copy, YMDD variation, et al), Liver CT scan or ultrasound (steatosis degree and fibrosis).
  • Differences in the anti-viral effect of entecavir among CHB patients and CHB + hepatic steatosis patients who received different drugs in a short term. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The common measurement includes serum biochemistry markers (ALT, AST, GGT, CRP, PT, APTT, AMA, UA, Chol, TG, TB, DB, ALP, fasting glucose, insulin, et al), virus markers (HBs-Ag, Hbe-Ag, anti-HBc-Ab, HBV genotype, HBV- DNA copy, YMDD variation, et al), Liver CT scan or ultrasound (steatosis degree and fibrosis).
Same as current
Not Provided
Not Provided
 
Influence of Hepatic Steatosis on the Therapeutic Effect of Entecavir in Chronic Hepatitis B Patients
Influence of Hepatic Steatosis on the Therapeutic Effect of Entecavir in Chronic Hepatitis B Patients-A Randomized, Double-Blinded, Controlled Trial

To investigate the influence of hepatic steatosis on the anti-viral effect of entecavir in chronic hepatitis B patients.

Chronic hepatitis B (CHB) affects approximately 360 million persons worldwide and is the most common cause of liver disease and affects over 10% of the general population in China. Hepatic steatosis is the main hepatic presentation of non- alcoholic fatty liver disease that is becoming another important liver disorder both in China and worldwide with economic development. It would be expected that hepatic steatosis might occur in CHB patients and recent studies show the frequency of steatosis in CHB ranges from 27% to 51%. However, the effect of steatosis on the anti-viral treatment in CHB patients is still vague. The aim of this RCT is to investigate the effect of steatosis on the therapeutic effect of entecavir in chronic hepatitis B patients. We will compare the anti-viral effect of entecavir among four groups: CHB group with entecavir therapy, CHB + steatosis group with entecavir therapy, CHB + steatosis group with entecavir + essentiale therapy and CHB + steatosis group with entecavir + vitamin E therapy. The speculated points are set as 3 months, 12 months and 15 months. Liver biopsy will be carried out at beginning and the 12th month. Other serum biochemical and viral markers are recorded as well as CT or ultrasound scan are repeated.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Chronic Hepatitis B
  • Hepatic Steatosis
  • Drug: entecavir
    entecavir 0.5 mg qd for 12 months
  • Drug: essentiale + entecavir
    entecavir 0.5 mg qd for 12 months,Essentiale 2 tablets tid in the first 3 months and 1 tablets tid in the rest 9 months
  • Drug: Vitamin E + entecavir
    entecavir 0.5 mg qd for 12 months, Vitamin E: 100 mg bid for 12 months
  • control group
    patients only with chronic hepatitis B
    Intervention: Drug: entecavir
  • Active Comparator: model group
    patients with chronic hepatitis B and hepatic steatosis
    Intervention: Drug: entecavir
  • Experimental: Essentiale group
    patients with chronic hepatitis B and hepatic steatosis
    Intervention: Drug: essentiale + entecavir
  • Experimental: treatment group 2
    patients with chronic hepatitis B and hepatic steatosis
    Intervention: Drug: Vitamin E + entecavir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1200
February 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients should be diagnosed with chronic hepatitis B infection and hepatic steatosis

  1. CHB infection

    • HBV-DNA ≥ 1×105 copies/ml;
    • HBeAg positive ;
    • ALT between the 2-10 times of the upper limit level
  2. hepatic steatosis According to the "Guidelines for the assessment and management of non-alcoholic fatty liver disease in the Asia-Pacific region: executive summary", with test of CT scan or B ultrasound and confirmation of liver biopsy(in portion of patients)

Exclusion Criteria:

  1. those receiving antiviral treatment before the study
  2. those on hepatoxic drug treatment,
  3. those consuming alcohol regularly or excessively,
  4. those diagnosed of cirrhosis, anti-HCV or anti-Delta positive patients,
  5. those diagnosed as having autoimmune or other metabolic liver diseases
  6. those have wilson's disease, PBC, PSC, IBD and other diseases that may influence the process and effect of therapy
  7. those who are pregnant, have mental disorder and were received anti-viral treatment
Both
18 Years to 70 Years
No
Contact: Xi Jin, phD 0086-571-87266532 jxfl007@hotmail.com
China
 
NCT01148576
NCTZJU201001
Yes
the first affiliated hospital, college of medicine, zhejiang university
Zhejiang University
Not Provided
Not Provided
Zhejiang University
June 2010

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