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

Chronic Hepatitis B Clinical Trial

Official title:

Influence of Hepatic Steatosis on the Therapeutic Effect of Entecavir in Chronic Hepatitis B Patients-A Randomized, Double-Blinded, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01148576
• Other study ID #: NCTZJU201001
• Status: Recruiting
• Phase: Phase 4
• First received: June 17, 2010
• Last updated: June 21, 2010
• Start date: June 2010
• Est. completion date: February 2012

Study information

• Verified date: June 2010
• Source: Zhejiang University
• Contact: Xi Jin, phD
• Phone: 0086-571-87266532
• Email: jxfl007[@]hotmail.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: February 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Fatty Liver
• Hepatic Steatosis
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

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

Locations

Country	Name	City	State
China	The first affiliated hospital, college of medicine, zhejiang university	Hangzhou	Zhejaing

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in the anti-viral effect of entecavir among CHB patients and CHB + hepatic steatosis patients who received different drugs	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).	12 months	No
Secondary	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.	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).	15 months	No
Secondary	Differences in the anti-viral effect of entecavir among CHB patients and CHB + hepatic steatosis patients who received different drugs in a short term.	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).	3 months	No