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The Changes of Plasmacytoid Dendritic Cells Frequency and Function During Antiviral Therapy

4. juli 2017 opdateret af: Yao Xie, Beijing Ditan Hospital

The Changes of Plasmacytoid Dendritic Cells Frequency and Function During Pegylated Interferon α-2a and Entecavir(ETV) Treatment in Patients With Chronic Hepatitis B.

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.

Studieoversigt

Status

Ukendt

Betingelser

Detaljeret beskrivelse

Pegylated interferon α-2a(Peg-IFN-α)and entecavir(ETV) drugs can inhibit viral replication , but Peg-IFN-α also play an important role in immune regulation . In hepatitis B infection, Plasmacytoid Dendritic Cells (pDCs) are the main effector cells in early antiviral innate immune response.Peg-IFN-α recommended as the first-line treatment has a higher chance to achieve HBeAg seroconversion and even HBsAg disappearance than entecavir(ETV) drugs, which may be related to the functional activation of pDCs in the case of hepatitis and the function enhancement of pDCs during Peg-IFN-α therapy. This study was aimed at investigating the changes of pDCs frequency and function, and the expression of costimulatory molecules CD86 during Peg-IFN-αandentecavir(ETV) therapy.Meanwhile,investigators want to explore whether the decline of HBsAg and HBeAg resulted in recovery of CD86+pDC function, or recovery of CD86 + pDC function led to the decrease of HBsAg and HBeAg. Several studies demonstrated that HBsAg and HBeAg could damage pDC function, and the loss of HBsAg and HBeAg led to recovery of CD86+pDC function.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Kina
    • Beijing
      • Beijing, Beijing, Kina, 100015
        • Rekruttering
        • Beijing Ditan Hospital,Capital Medical University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
the change of pDC%
Tidsramme: after treatment 24 weeks
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%
Tidsramme: after treatment 24 weeks
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)
Tidsramme: after treatment 24 weeks
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
Tidsramme: after treatment 24 weeks
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
the change of HBVDNA levels (IU/ML)
Tidsramme: after treatment 48 weeks
the curative effect of antiviral therapy will be evaluated by HBV DNA levels
after treatment 48 weeks
the change of ALT levels(U/L)
Tidsramme: after treatment 48 weeks
the curative effect of antiviral therapy will be evaluated by ALT levels
after treatment 48 weeks
the change of AST levels(U/L)
Tidsramme: after treatment 48 weeks
the curative effect of antiviral therapy will be evaluated by AST levels
after treatment 48 weeks
the change of HBsAg levels (IU/ML)
Tidsramme: after treatment 48 weeks
the curative effect of antiviral therapy will be evaluated by HBsAg levels
after treatment 48 weeks
the change of HBeAg levels (IU/ML)
Tidsramme: after treatment 48 weeks
the curative effect of antiviral therapy will be evaluated by HBeAg levels
after treatment 48 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Beijing Ditan Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. januar 2016

Primær færdiggørelse (Forventet)

1. december 2017

Studieafslutning (Forventet)

1. december 2017

Datoer for studieregistrering

Først indsendt

30. juni 2017

Først indsendt, der opfyldte QC-kriterier

4. juli 2017

Først opslået (Faktiske)

7. juli 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • DTXY011

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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