NCT02532413

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 25, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 25, 2015

Status Verified

August 1, 2015

Enrollment Period

1.1 years

First QC Date

July 24, 2015

Last Update Submit

August 22, 2015

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with HBsAg serological response

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

    at week 48 of treatment

Secondary Outcomes (3)

  • Changes in serum HBV DNA levels

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

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

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

  • Proportion of patients with HBeAg serological response

    at week 48 of treatment

Study Arms (4)

HBeAg(+):Poly IC+Entecavir

EXPERIMENTAL

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 ICDrug: Entecavir

HBeAg(+):Entecavir

ACTIVE COMPARATOR

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

Drug: Entecavir

HBeAg(-):Poly IC+Entecavir

EXPERIMENTAL

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 ICDrug: Entecavir

HBeAg(-):Entecavir

ACTIVE COMPARATOR

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

Drug: Entecavir

Interventions

Poly ICDRUG

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

Also known as: Polyinosinic-polycytidylic acid injection
HBeAg(+):Poly IC+EntecavirHBeAg(-):Poly IC+Entecavir
EntecavirDRUG

Entecavir can inhibit the replication of HBV.

Also known as: Leiyide
HBeAg(+):EntecavirHBeAg(+):Poly IC+EntecavirHBeAg(-):EntecavirHBeAg(-):Poly IC+Entecavir

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 .

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Infectious Disease of Wu Han Union Hospital

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Poly I-Centecavir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Poly CPolyribonucleotidesPolynucleotidesNucleotidesNucleic Acids, Nucleotides, and NucleosidesPoly I

Study Officials

  • Liang D Yang, M.D.

    Huanzhong University of Science and Technology

    STUDY CHAIR

Central Study Contacts

Xin Zheng, M.D.

CONTACT

(00)-86-02785726732zheng2015uh@163.com

Jin Tian, M.S.

CONTACT

(00)-86-02785726132tjxhtj@126.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 24, 2015

First Posted

August 25, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2017

Last Updated

August 25, 2015

Record last verified: 2015-08

Locations

CN(1)