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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

Tracking Information
First Submitted Date June 30, 2017
First Posted Date July 7, 2017
Last Update Posted Date July 7, 2017
Study Start Date January 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 4, 2017)
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 4, 2017)
  • 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
  • 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
  • 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
  • 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
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Changes of Plasmacytoid Dendritic Cells Frequency and Function During Antiviral Therapy
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.
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Chronic Hepatitis B Infection
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: July 4, 2017)
120
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03210467
Other Study ID Numbers DTXY011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Yao Xie, Beijing Ditan Hospital
Study Sponsor Beijing Ditan Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Beijing Ditan Hospital
Verification Date July 2017