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

Huazhong University of Science and Technology

Status and phase: Unknown; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: Entecavir; Drug: Poly IC

Study type: Interventional

Funder types: Other

Identifiers

NCT02532413

81461130019C5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 4 patient groups

HBeAg(+):Poly IC+Entecavir

Experimental group

Description:

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

Treatment:

Drug: Poly IC

Drug: Entecavir

HBeAg(+):Entecavir

Active Comparator group

Description:

45 subjects(HBeAg-positive chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.

Treatment:

Drug: Entecavir

HBeAg(-):Poly IC+Entecavir

Experimental group

Description:

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

Treatment:

Drug: Poly IC

Drug: Entecavir

HBeAg(-):Entecavir

Active Comparator group

Description:

45 subjects(HBeAg-negative chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.

Treatment:

Drug: Entecavir