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

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ClinicalTrials.gov Identifier: NCT03210467
Recruitment Status : Unknown
Verified July 2017 by Yao Xie, Beijing Ditan Hospital.
Recruitment status was:  Recruiting
First Posted : July 7, 2017
Last Update Posted : July 7, 2017
Sponsor:
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital

Study Description
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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.

Condition or disease
Chronic Hepatitis B Infection

Detailed Description:
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.
Study Design
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Changes of Plasmacytoid Dendritic Cells Frequency and Function During Pegylated Interferon α-2a and Entecavir(ETV) Treatment in Patients With Chronic Hepatitis B.
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. the change of pDC% [ Time Frame: 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.

  2. the change of CD86+pDC% [ Time Frame: after treatment 24 weeks ]
    CD86+pDC% will be measured by flow cytometry after Pegylated Interferon α-2a and entecavir(ETV) Treatment 24 weeks.

  3. the change of mean fluorescence intensity of costimulatory molecules CD86(CD86-MFI) [ Time Frame: 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.

  4. the change of absolute molecular counting of costimulatory molecules CD86 [ Time Frame: 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.


Secondary Outcome Measures :
  1. the change of HBVDNA levels (IU/ML) [ Time Frame: after treatment 48 weeks ]
    the curative effect of antiviral therapy will be evaluated by HBV DNA levels

  2. the change of ALT levels(U/L) [ Time Frame: after treatment 48 weeks ]
    the curative effect of antiviral therapy will be evaluated by ALT levels

  3. the change of AST levels(U/L) [ Time Frame: after treatment 48 weeks ]
    the curative effect of antiviral therapy will be evaluated by AST levels

  4. the change of HBsAg levels (IU/ML) [ Time Frame: after treatment 48 weeks ]
    the curative effect of antiviral therapy will be evaluated by HBsAg levels

  5. the change of HBeAg levels (IU/ML) [ Time Frame: after treatment 48 weeks ]
    the curative effect of antiviral therapy will be evaluated by HBeAg levels


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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.
Criteria

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
Contacts and Locations
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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): NCT03210467


Contacts
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Contact: Yao Xie, MD 8610-84322489 xieyao00120184@sina.com

Locations
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China, Beijing
Beijing Ditan hospital,Capital Medical University Recruiting
Beijing, Beijing, China, 100015
Contact: Yao Xie, doctor    8613501093293    xieyao00120184@sina.com   
Principal Investigator: Yao Xie, doctor         
Sponsors and Collaborators
Beijing Ditan Hospital
More Information
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Responsible Party: Yao Xie, Head of liver diseases center, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT03210467    
Other Study ID Numbers: DTXY011
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: July 7, 2017
Last Verified: July 2017
Keywords provided by Yao Xie, Beijing Ditan Hospital:
chronic hepatitis B
hepatitis B virus
Pegylated Interferon α-2a
entecavir
Plasmacytoid Dendritic Cells
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
 Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections