NCT03210467

Brief Summary

Pegylated interferon(IFN) α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while entecavir(ETV) drugs only inhibit viral replication. In hepatitis B infection, Plasmacytoid Dendritic Cells（pDCs） are the main effector cells in early antiviral innate immune response. This study was aimed at investigating the changes of pDCs frequency and function, and the expression of costimulatory molecules CD86(Cluster of Differentiation antigen 86) during Peg-IFN-αand entecavir(ETV) therapy.Meanwhile, investigators want to verify whether Peg-IFN-α suppressed the virus and the reduction of virus led to the recovery of pDCs function, or Peg-IFN-α enhanced pDCs function which gave rise to the decline of the virus.

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2016

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

January 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 7, 2017

Status Verified

July 1, 2017

Enrollment Period

1.9 years

First QC Date

June 30, 2017

Last Update Submit

July 4, 2017

Conditions

Chronic Hepatitis B Infection

Keywords

chronic hepatitis Bhepatitis B virusPegylated Interferon α-2aentecavirPlasmacytoid Dendritic Cells

Outcome Measures

Primary Outcomes (4)

  • the change of pDC%

    The host immune function will be evaluated by pDC. pDC% will be measured by flow cytometry after Pegylated Interferon α-2a and entecavir(ETV) Treatment 24 weeks.

    after treatment 24 weeks

  • the change of CD86+pDC%

    CD86+pDC% will be measured by flow cytometry after Pegylated Interferon α-2a and entecavir(ETV) Treatment 24 weeks.

    after treatment 24 weeks

  • the change of mean fluorescence intensity of costimulatory molecules CD86(CD86-MFI)

    mean fluorescence intensity of costimulatory molecules CD86(CD86-MFI) will be measured by flow cytometry after Pegylated Interferon α-2a and entecavir(ETV) Treatment 24 weeks.

    after treatment 24 weeks

  • the change of absolute molecular counting of costimulatory molecules CD86

    absolute molecular counting of costimulatory molecules CD86 (CD86-ABC) will be measured by flow cytometry after Pegylated Interferon α-2a and entecavir(ETV) Treatment 24 weeks.

    after treatment 24 weeks

Secondary Outcomes (5)

  • the change of HBVDNA levels (IU/ML)

    after treatment 48 weeks

  • the change of ALT levels(U/L)

    after treatment 48 weeks

  • the change of AST levels(U/L)

    after treatment 48 weeks

  • the change of HBsAg levels (IU/ML)

    after treatment 48 weeks

  • the change of HBeAg levels (IU/ML)

    after treatment 48 weeks

Study Arms (2)

experimental group

patients who were untreated ever in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly till 48 weeks.

control group

patients who were untreated ever in immune-active phase took entecavir(ETV) for maintenance treatment.

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

the population in this study was composed of HBeAg positive chronic hepatitis B patients defined as HBsAg positive, HBeAg positive, and detectable HBVDNA load with ALT(alanine aminotransferase) level ≥190 U/L for more than 6 months.

You may qualify if:

  • HBsAg and HBeAg positive for more than 6 months, HBVDNA detectable with ALT(alanine aminotransferase) level abnormal lasted for three months and at least time190 IU/L or liver puncture biopsy demonstrated apparent inflammation, never treated before enrolled.

You may not qualify if:

  • Active consumption of alcohol and/or drugs
  • Co-infection with human immunodeficiency virus, hepatitis C virus, or hepatitis D virus
  • History of autoimmune hepatitis
  • Psychiatric disease
  • Evidence of neoplastic diseases of the liver

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Ditan hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yao Xie, MD

CONTACT

8610-84322489xieyao00120184@sina.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of liver diseases center

Study Record Dates

First Submitted

June 30, 2017

First Posted

July 7, 2017

Study Start

January 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

July 7, 2017

Record last verified: 2017-07

Locations

CN(1)