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

NCT ID: NCT01148576

Last Updated: 2010-06-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-02-29

Brief Summary

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

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.

Conditions

Chronic Hepatitis B; Hepatic Steatosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

control group

patients only with chronic hepatitis B

Group Type: OTHER

entecavir

Intervention Type: DRUG

entecavir 0.5 mg qd for 12 months

model group

patients with chronic hepatitis B and hepatic steatosis

Group Type: ACTIVE_COMPARATOR

entecavir

Intervention Type: DRUG

entecavir 0.5 mg qd for 12 months

Essentiale group

patients with chronic hepatitis B and hepatic steatosis

Group Type: EXPERIMENTAL

essentiale + entecavir

Intervention Type: DRUG

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

treatment group 2

patients with chronic hepatitis B and hepatic steatosis

Group Type: EXPERIMENTAL

Vitamin E + entecavir

Intervention Type: DRUG

entecavir 0.5 mg qd for 12 months, Vitamin E: 100 mg bid for 12 months

Interventions

entecavir

entecavir 0.5 mg qd for 12 months

Intervention Type: DRUG

entecavir

entecavir 0.5 mg qd for 12 months

Intervention Type: 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

Intervention Type: DRUG

Vitamin E + entecavir

entecavir 0.5 mg qd for 12 months, Vitamin E: 100 mg bid for 12 months

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

the first affiliated hospital, college of medicine, zhejiang university

Locations

The first affiliated hospital, college of medicine, zhejiang university

Hangzhou, Zhejaing, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xi Jin, phD

Role: CONTACT

jxfl007@hotmail.com

0086-571-87266532

Other Identifiers

NCTZJU201001

Identifier Type: -

Identifier Source: org_study_id