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Trial record 83 of 518 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2015 by Wuhan Union Hospital, China
Sponsor:
Information provided by (Responsible Party):
Xin Zheng, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier:
NCT02532413
First received: July 24, 2015
Last updated: August 22, 2015
Last verified: August 2015
  Purpose
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 Intervention Phase
Chronic Hepatitis B
Drug: Poly IC
Drug: Entecavir
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Antiviral Efficacy of Entecavir Monotherapy and Combination Treatment With Poly IC for Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Wuhan Union Hospital, China:

Primary Outcome Measures:
  • Proportion of patients with HBsAg serological response [ Time Frame: at week 48 of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: at week 4,12,24,36,48,72,96 of treatment ] [ Designated as safety issue: No ]
    Changes in serum HBV DNA levels during 48 weeks 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 ] [ Designated as safety issue: No ]
    Biochemical response as assessed by the serum levels of ALT, AST, TB, etc.

  • Proportion of patients with HBeAg serological response [ Time Frame: at week 48 of treatment ] [ Designated as safety issue: No ]
    The proportion of patients who achieve HBeAg serological response as assessed by the rate of HBeAg loss or HBeAg seroconversion.


Estimated Enrollment: 180
Study Start Date: July 2015
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02532413

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

Locations
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
Study Chair: Liang D Yang, M.D. Huanzhong University of Science and Technology
  More Information

Responsible Party: Xin Zheng, Professor, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier: NCT02532413     History of Changes
Other Study ID Numbers: 81461130019C5 
Study First Received: July 24, 2015
Last Updated: August 22, 2015
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Entecavir
Antiviral Agents
Poly I-C
Anti-Infective Agents
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016