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

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ClinicalTrials.gov Identifier: NCT02532413
Recruitment Status : Unknown
Verified August 2015 by Xin Zheng, Wuhan Union Hospital, China.
Recruitment status was:  Recruiting
First Posted : August 25, 2015
Last Update Posted : August 25, 2015
Sponsor:
Information provided by (Responsible Party):
Xin Zheng, 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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Drug: Poly IC Drug: Entecavir Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Antiviral Efficacy of Entecavir Monotherapy and Combination Treatment With Poly IC for Chronic Hepatitis B
Study Start Date : July 2015
Estimated Primary Completion Date : August 2016
Estimated Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Entecavir

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

Drug: Poly IC
Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir.
Other Name: Polyinosinic-polycytidylic acid injection

Drug: Entecavir
Entecavir can inhibit the replication of HBV.
Other Name: Leiyide

Active Comparator: HBeAg(+):Entecavir
45 subjects(HBeAg-positive chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.
Drug: Entecavir
Entecavir can inhibit the replication of HBV.
Other Name: 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

Drug: Poly IC
Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir.
Other Name: Polyinosinic-polycytidylic acid injection

Drug: Entecavir
Entecavir can inhibit the replication of HBV.
Other Name: Leiyide

Active Comparator: HBeAg(-):Entecavir
45 subjects(HBeAg-negative chronic hepatitis B). Drug: Entecavir 0.5mg, P.O.,qd, duration:48 weeks.
Drug: Entecavir
Entecavir can inhibit the replication of HBV.
Other Name: Leiyide




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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

  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532413


Contacts
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Contact: Xin Zheng, M.D. (00)-86-02785726732 zheng2015uh@163.com
Contact: Jin Tian, M.S. (00)-86-02785726132 tjxhtj@126.com

Locations
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China, Hubei
Department of Infectious Disease of Wu Han Union Hospital Recruiting
Wuhan, Hubei, China, 430022
Contact: Xin Zheng, M.D.    (00)-86-02785726732    zheng2015uh@163.com   
Contact: Jin Tian, M.S.    (00)-86-02785726132    tjxhtj@126.com   
Sponsors and Collaborators
Wuhan Union Hospital, China
Investigators
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Study Chair: Liang D Yang, M.D. Huanzhong University of Science and Technology

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Responsible Party: Xin Zheng, Professor, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT02532413     History of Changes
Other Study ID Numbers: 81461130019C5
First Posted: August 25, 2015    Key Record Dates
Last Update Posted: August 25, 2015
Last Verified: August 2015
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Antiviral Agents
Entecavir
Poly I-C
Anti-Infective Agents
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs