Antiviral Efficacy of the Combination Treatment With Poly IC and Entecavir for Chronic Hepatitis B

Phase 4

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Poly IC; Drug: Entecavir

• Registration Number: NCT02532413
• Lead Sponsor: Wuhan Union Hospital, China

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.

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-24
• Status Verified: 2015-08
• Study First Submitted QC: 2015-08-22
• Last Update Submitted: 2015-08-22
• Study First Posted: 2015-08-25
• Last Update Posted: 2015-08-25
• Primary Completion: 2016-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HBeAg(-):Poly IC+Entecavir	Poly IC	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
HBeAg(+):Poly IC+Entecavir	Poly IC	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
HBeAg(-):Poly IC+Entecavir	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
HBeAg(+):Poly IC+Entecavir	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
HBeAg(+):Entecavir	Entecavir	45 subjects(HBeAg-positive chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.
HBeAg(-):Entecavir	Entecavir	45 subjects(HBeAg-negative chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.

Primary Outcome Measures

Name	Time	Method
Proportion of patients with HBsAg serological response	at week 48 of treatment	The proportion of patients who achieve HBsAg serological response as assessed by the rate of HBsAg seroconversion.

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with HBeAg serological response	at week 48 of treatment	The proportion of patients who achieve HBeAg serological response as assessed by the rate of HBeAg loss or HBeAg seroconversion.
Changes in serum HBV DNA levels	at week 4，12，24，36，48，72，96 of treatment	Changes in serum HBV DNA levels during 48 weeks 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	Biochemical response as assessed by the serum levels of ALT, AST, TB, etc.

Trial Locations

Locations (1)

Department of Infectious Disease of Wu Han Union Hospital; 🇨🇳 Wuhan, Hubei, China