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

August 22, 2015 updated by: Xin Zheng, Wuhan Union Hospital, China

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jin Tian, M.S.
  • Phone Number: (00)-86-02785726132
  • Email: tjxhtj@126.com

Study Locations

    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Department of Infectious Disease of Wu Han Union Hospital
        • Contact:
        • Contact:
          • Jin Tian, M.S.
          • Phone Number: (00)-86-02785726132
          • Email: tjxhtj@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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

Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir.
Other Names:
  • Polyinosinic-polycytidylic acid injection
Entecavir can inhibit the replication of HBV.
Other Names:
  • Leiyide
Active Comparator: HBeAg(+):Entecavir
45 subjects(HBeAg-positive chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.
Entecavir can inhibit the replication of HBV.
Other Names:
  • Leiyide
Experimental: 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

Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir.
Other Names:
  • Polyinosinic-polycytidylic acid injection
Entecavir can inhibit the replication of HBV.
Other Names:
  • Leiyide
Active Comparator: HBeAg(-):Entecavir
45 subjects(HBeAg-negative chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.
Entecavir can inhibit the replication of HBV.
Other Names:
  • Leiyide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at week 48 of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in serum HBV DNA levels
Time Frame: at week 4,12,24,36,48,72,96 of treatment
Changes in serum HBV DNA levels during 48 weeks of treatment
at week 4,12,24,36,48,72,96 of treatment
Biochemical Response (the serum levels of ALT and AST) Biochemical Response
Time Frame: 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.
at week 1,2,4,8,12,16,20,24,36,48,72,96 of treatment
Proportion of patients with HBeAg serological response
Time Frame: 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.
at week 48 of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Liang D Yang, M.D., Huanzhong University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2017

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

August 22, 2015

First Posted (Estimate)

August 25, 2015

Study Record Updates

Last Update Posted (Estimate)

August 25, 2015

Last Update Submitted That Met QC Criteria

August 22, 2015

Last Verified

August 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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