Trial record 1 of 1 for:    NCT01148576
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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
  Purpose

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


Condition Intervention Phase
Chronic Hepatitis B
Hepatic Steatosis
Drug: entecavir
Drug: essentiale + entecavir
Drug: Vitamin E + entecavir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Hepatic Steatosis on the Therapeutic Effect of Entecavir in Chronic Hepatitis B Patients-A Randomized, Double-Blinded, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Zhejiang University:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).


Estimated Enrollment: 1200
Study Start Date: June 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
control group
patients only with chronic hepatitis B
Drug: entecavir
entecavir 0.5 mg qd for 12 months
Active Comparator: model group
patients with chronic hepatitis B and hepatic steatosis
Drug: entecavir
entecavir 0.5 mg qd for 12 months
Experimental: Essentiale group
patients with chronic hepatitis B and hepatic steatosis
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
Experimental: treatment group 2
patients with chronic hepatitis B and hepatic steatosis
Drug: Vitamin E + entecavir
entecavir 0.5 mg qd for 12 months, Vitamin E: 100 mg bid for 12 months

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01148576

Contacts
Contact: Xi Jin, phD 0086-571-87266532 jxfl007@hotmail.com

Locations
China, Zhejaing
The first affiliated hospital, college of medicine, zhejiang university Recruiting
Hangzhou, Zhejaing, China, 310003
Sub-Investigator: Yi da Yang, PhD         
Sponsors and Collaborators
Zhejiang University
  More Information

No publications provided

Responsible Party: the first affiliated hospital, college of medicine, zhejiang university
ClinicalTrials.gov Identifier: NCT01148576     History of Changes
Other Study ID Numbers: NCTZJU201001
Study First Received: June 17, 2010
Last Updated: June 21, 2010
Health Authority: China: Ministry of Health

Keywords provided by Zhejiang University:
hepatic steatosis, chronic hepatitis B, entecavir

Additional relevant MeSH terms:
Fatty Liver
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
Essential 303 forte
Vitamins
Entecavir
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Micronutrients
Growth Substances
Adjuvants, Immunologic

ClinicalTrials.gov processed this record on July 22, 2014