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The Changes of CD8+T Cells Frequency and Function During Antiviral Therapy

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ClinicalTrials.gov Identifier: NCT03209037
Recruitment Status : Unknown
Verified July 2017 by Yao Xie, Beijing Ditan Hospital.
Recruitment status was:  Recruiting
First Posted : July 6, 2017
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital

Tracking Information
First Submitted Date  ICMJE June 30, 2017
First Posted Date  ICMJE July 6, 2017
Last Update Posted Date July 12, 2017
Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
the changes of CD8+T Cells [ Time Frame: at baseline and at treatment week 12, 24. ]
the changes of CD8+T cells%, CD69+CD8+T cells%, CD69MFI, CD69ABC, CD178+CD8+T cells%, CD178MFI, CD178ABC,IFN-AR2+CD8+T cells%, IFNAR2MFI, IFNAR2ABC will be measured by flow cytometry during Pegylated Interferon α-2a and Nucleoside Analogues Treatment every 3 months.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2017)
  • the change of HBVDNA levels (IU/ML) [ Time Frame: at baseline and at treatment 12, 24, 36, 48 weeks ]
    the curative effect of antiviral therapy will be evaluated by HBV markers
  • the change of ALT levels(U/L) [ Time Frame: at baseline and at treatment 12, 24, 36, 48 weeks ]
    the curative effect of antiviral therapy will be evaluated by ALT levels
  • the change of AST levels(U/L) [ Time Frame: at baseline and at treatment 12, 24, 36, 48 weeks ]
    the curative effect of antiviral therapy will be evaluated by AST levels
Original Secondary Outcome Measures  ICMJE
 (submitted: July 3, 2017)
  • the change of HBVDNA levels (IU/ML) [ Time Frame: at baseline and at treatment 12, 24, 36, 48 weeks ]
    the curative effect of antiviral therapy will be evaluated by HBV markers and HBV DNA levels and liver function
  • the change of ALT levels(U/L) [ Time Frame: at baseline and at treatment 12, 24, 36, 48 weeks ]
    the curative effect of antiviral therapy will be evaluated by HBV markers and HBV DNA levels and liver function
  • the change of AST levels(U/L) [ Time Frame: at baseline and at treatment 12, 24, 36, 48 weeks ]
    the curative effect of antiviral therapy will be evaluated by HBV markers and HBV DNA levels and liver function
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Changes of CD8+T Cells Frequency and Function During Antiviral Therapy
Official Title  ICMJE The Changes of CD8+T Cells Frequency and Function During Pegylated Interferon α-2a and Nucleoside Analogues Treatment in Patients With Chronic Hepatitis B
Brief Summary Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, CD8+T cells are the main effector cells in adaptive immune response. This study was aimed at investigating the changes of CD8+T cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg-IFN-α suppressed the virus and the reduction of virus led to the recovery of CD8+T cells function, or Peg IFN - alpha enhanced CD8+T cells function which gave rise to the decline of the virus.
Detailed Description Pegylated interferon α-2a(Peg-IFN-α)and Nucleoside analog(ue) drugs can inhibit viral replication , but Peg-IFN-α also play an important role in immune regulation. In hepatitis B infection, CD8+T cells are the main effector cells in adaptive immune response.Peg-IFN-α recommended as the first-line treatment has a higher chance to achieve HBeAg seroconversion and even HBsAg disappearance than nucleoside analog(ue) drugs, which may be related to the functional activation of CD8+T cells in the case of hepatitis and the function enhancement of CD8+T cells during Peg-IFN-α therapy. This study was aimed at investigating the changes of CD8+T cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to explore whether the decline of HBsAg and HBeAg resulted in recovery of CD8+T cells function, or recovery of CD8+T cells function led to the decrease of HBsAg and HBeAg. Several studies demonstrated that HBsAg and HBeAg could damage CD8+T cells function, and the loss of HBsAg and HBeAg led to recovery of CD8+T cells function.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Chronic Hepatitis B Infection
Intervention  ICMJE Drug: Peginterferon Alfa-2a
patients untreated in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly in experiment group.
Other Name: Peg-IFN-α
Study Arms  ICMJE
  • Experimental: 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.
    Intervention: Drug: Peginterferon Alfa-2a
  • No Intervention: control group
    patients who were untreated ever in immune-active phase took Nucleoside Analogues 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  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 3, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • HBsAg and HBeAg positive for more than 6 months, HBV DNA detectable with ALT 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03209037
Other Study ID Numbers  ICMJE DTXY014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Yao Xie, Beijing Ditan Hospital
Study Sponsor  ICMJE Beijing Ditan Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Beijing Ditan Hospital
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP