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

Zhejiang University

Status and phase: Unknown; Phase 4

Conditions: Chronic Hepatitis B; Hepatic Steatosis

Treatments: Drug: Vitamin E + entecavir; Drug: entecavir; Drug: essentiale + entecavir

Study type: Interventional

Funder types: Other

Identifiers

NCT01148576

NCTZJU201001

Details and patient eligibility

About

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

Full 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.

Enrollment: 1,200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,200 participants in 4 patient groups

control group

Other group

Description:

patients only with chronic hepatitis B

Treatment:

Drug: entecavir

Drug: entecavir

model group

Active Comparator group

Description:

patients with chronic hepatitis B and hepatic steatosis

Treatment:

Drug: entecavir

Drug: entecavir

Essentiale group

Experimental group

Description:

patients with chronic hepatitis B and hepatic steatosis

Treatment:

Drug: essentiale + entecavir

treatment group 2

Experimental group

Description:

patients with chronic hepatitis B and hepatic steatosis

Treatment:

Drug: Vitamin E + entecavir