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

Primary Purpose

Chronic Hepatitis B

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Poly IC

Entecavir

About this trial

This is an interventional treatment trial for Chronic Hepatitis B

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

Department of Infectious Disease of Wu Han Union HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

HBeAg(+):Poly IC+Entecavir

HBeAg(+):Entecavir

HBeAg(-):Poly IC+Entecavir

HBeAg(-):Entecavir

Arm 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

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

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

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

Outcomes

Primary Outcome Measures

Proportion of patients with HBsAg serological response

The proportion of patients who achieve HBsAg serological response as assessed by the rate of HBsAg seroconversion.

Secondary Outcome Measures

Changes in serum HBV DNA levels

Changes in serum HBV DNA levels during 48 weeks of treatment

Biochemical Response （the serum levels of ALT and AST） Biochemical Response

Biochemical response as assessed by the serum levels of ALT, AST, TB, etc.

Proportion of patients with HBeAg serological response

The proportion of patients who achieve HBeAg serological response as assessed by the rate of HBeAg loss or HBeAg seroconversion.

Full Information

NCT ID

NCT02532413

First Posted

July 24, 2015

Last Updated

August 22, 2015

Sponsor

Wuhan Union Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT02532413

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2015 (undefined)

Primary Completion Date

August 2016 (Anticipated)

Study Completion Date

August 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Wuhan Union Hospital, China

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Hepatitis B

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

HBeAg(+):Poly IC+Entecavir

Arm Type

Experimental

Arm Description

Arm Title

HBeAg(+):Entecavir

Arm Type

Active Comparator

Arm Description

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

Arm Title

HBeAg(-):Poly IC+Entecavir

Arm Type

Experimental

Arm Description

Arm Title

HBeAg(-):Entecavir

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Poly IC

Other Intervention Name(s)

Polyinosinic-polycytidylic acid injection

Intervention Description

Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir.

Intervention Type

Drug

Intervention Name(s)

Entecavir

Other Intervention Name(s)

Leiyide

Intervention Description

Entecavir can inhibit the replication of HBV.

Primary Outcome Measure Information:

Title

Proportion of patients with HBsAg serological response

Description

The proportion of patients who achieve HBsAg serological response as assessed by the rate of HBsAg seroconversion.

Time Frame

at week 48 of treatment

Secondary Outcome Measure Information:

Title

Changes in serum HBV DNA levels

Description

Changes in serum HBV DNA levels during 48 weeks of treatment

Time Frame

at week 4，12，24，36，48，72，96 of treatment

Title

Biochemical Response （the serum levels of ALT and AST） Biochemical Response

Description

Biochemical response as assessed by the serum levels of ALT, AST, TB, etc.

Time Frame

at week 1，2，4，8，12，16，20，24，36，48，72，96 of treatment

Title

Proportion of patients with HBeAg serological response

Description

The proportion of patients who achieve HBeAg serological response as assessed by the rate of HBeAg loss or HBeAg seroconversion.

Time Frame

at week 48 of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xin Zheng, M.D.

Phone

(00)-86-02785726732

zheng2015uh@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Jin Tian, M.S.

Phone

(00)-86-02785726132

tjxhtj@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Liang D Yang, M.D.

Organizational Affiliation

Huanzhong University of Science and Technology

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Infectious Disease of Wu Han Union Hospital

City

Wuhan

State/Province

Hubei

ZIP/Postal Code

430022

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xin Zheng, M.D.

Phone

(00)-86-02785726732

zheng2015uh@163.com

First Name & Middle Initial & Last Name & Degree

Jin Tian, M.S.

Phone

(00)-86-02785726132

tjxhtj@126.com

12. IPD Sharing Statement

Learn more about this trial

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

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