Comparison of Antiviral Efficacy of Entecavir Monotherapy and Combination Treatment With Poly IC for Chronic Hepatitis B
Overview
- Phase
- Phase 4
- Intervention
- Poly IC
- Conditions
- Chronic Hepatitis B
- Sponsor
- Wuhan Union Hospital, China
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Proportion of patients with HBsAg serological response
- Last Updated
- 10 years ago
Overview
Brief Summary
The purpose of this study is to investigate antiviral efficacy of the combination treatment with Poly IC and Entecavir and compare with the efficacy of Entecavir mono-therapy for chronic hepatitis B.
Detailed Description
In this study, the patients with chronic HBV infection will be divided into two groups: HBeAg (+) and HBeAg (-) group. Each group will be divided into two subgroups, which are treated with combination treatment of Entecavir and Poly IC and Entecavir monotherapy respectively. All the patients will be followed up for one year. From this study, the investigators want to study if Poly IC can enhance antiviral efficacy of Entecavir for chronic hepatitis B.
Investigators
Xin Zheng
Professor
Wuhan Union Hospital, China
Eligibility Criteria
Inclusion Criteria
- •HBsAg positive for more than 6 months.
- •Having been treated wit Entecavir and the level of HBV DNA is under 1000 copies/ml.
- •ALT ≤10×ULN， TB \<2ULN .
Exclusion Criteria
- •Previous antiviral treatment for HBV.
- •Co infection of HIV, HCV, HEV, HAV, or HAV.
- •Evidence of hepatic carcinoma.
- •Evidence of autoimmune disease.
- •Evidence of thyroid disease.
- •History of mental sickness.
Arms & Interventions
HBeAg(+):Poly IC+Entecavir
45 subjects(HBeAg-positive chronic hepatitis B). Combination therapy will last 24 weeks from 0 week. Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks. Drug: PolyIC 2mg,im,qod,duration:from 0 week to 24th week
Intervention: Poly IC
HBeAg(+):Poly IC+Entecavir
45 subjects(HBeAg-positive chronic hepatitis B). Combination therapy will last 24 weeks from 0 week. Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks. Drug: PolyIC 2mg,im,qod,duration:from 0 week to 24th week
Intervention: Entecavir
HBeAg(+):Entecavir
45 subjects(HBeAg-positive chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.
Intervention: Entecavir
HBeAg(-):Poly IC+Entecavir
45 subjects(HBeAg-negative chronic hepatitis B). Combination treatment will last 24 weeks from 0 week. Drug: Enticavir 0.5mg, P.O.,qd, duration:48 weeks. Drug: PolyIC 2mg,im,qod,duration:from 0 week to 24th week
Intervention: Poly IC
HBeAg(-):Poly IC+Entecavir
45 subjects(HBeAg-negative chronic hepatitis B). Combination treatment will last 24 weeks from 0 week. Drug: Enticavir 0.5mg, P.O.,qd, duration:48 weeks. Drug: PolyIC 2mg,im,qod,duration:from 0 week to 24th week
Intervention: Entecavir
HBeAg(-):Entecavir
45 subjects(HBeAg-negative chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.
Intervention: Entecavir
Outcomes
Primary Outcomes
Proportion of patients with HBsAg serological response
Time Frame: at week 48 of treatment
The proportion of patients who achieve HBsAg serological response as assessed by the rate of HBsAg seroconversion.
Secondary Outcomes
- Proportion of patients with HBeAg serological response(at week 48 of treatment)
- Changes in serum HBV DNA levels(at week 4，12，24，36，48，72，96 of treatment)
- Biochemical Response （the serum levels of ALT and AST） Biochemical Response(at week 1，2，4，8，12，16，20，24，36，48，72，96 of treatment)