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The Changes of CD4+T Cells Frequency and Function During Antiviral Therapy

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ClinicalTrials.gov Identifier: NCT03209011
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

Study Description
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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, CD4+T Cells are the main effector cells in adaptive immune response. This study was aimed at investigating the changes of CD4+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 - alpha suppressed the virus and the reduction of virus led to the recovery of CD4+T Cells function, or Peg IFN - alpha enhanced CD4+T Cells function which gave rise to the decline of the virus.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis B Infection Drug: Peginterferon Alfa-2a Phase 4

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, CD4+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 CD4+T Cells in the case of hepatitis and the function enhancement of CD4+T Cells during Peg-IFN-α therapy. This study was aimed at investigating the changes of CD4+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 CD4+T cells function, or recovery of CD4+T Cells function led to the decrease of HBsAg and HBeAg. Several studies demonstrated that HBsAg and HBeAg could damage CD4+T cells function, and the loss of HBsAg and HBeAg led to recovery of CD4+T cells function.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Changes of CD4+T Cells Frequency and Function During Pegylated Interferon α-2a and Nucleoside Analogues Treatment in Patients With Chronic Hepatitis B
Study Start Date : January 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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Arms and Interventions
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Arm Intervention/treatment
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.
 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
No Intervention: control group
patients who were untreated ever in immune-active phase took Nucleoside Analogues for maintenance treatment.


Outcome Measures
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Primary Outcome Measures :
  1. the changes of CD4+T Cells [ Time Frame: at baseline and at treatment week 12, 24. ]
    the changes of CD4+T cells%, CD62L+T cells%, CD62L-T cells%, CD62L+/ CD62L-, CD69+CD4+T cells%, CD69MFI, CD69ABC, IFN-AR2+CD4+T cells%, IFNAR2MFI, IFNAR2ABC will be measured by flow cytometry during Pegylated Interferon α-2a and Nucleoside Analogues treatment every 3 months.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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


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
Criteria

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
Contacts and Locations
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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): NCT03209011


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
Yao Xie
More Information
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Responsible Party: Yao Xie, Head of liver diseases center, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT03209011    
Other Study ID Numbers: DTXY013
First Posted: July 6, 2017    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017
Keywords provided by Yao Xie, Beijing Ditan Hospital:
chronic hepatitis B
hepatitis B virus
CD4+T Cells
Pegylated Interferon α-2a
Nucleoside Analogues
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
 Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents