This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback
Trial record 115 of 373 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

The Changes of Treg Cells Frequency and Function During Antiviral Therapy

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Yao Xie, Beijing Ditan Hospital
Sponsor:
Information provided by (Responsible Party):
Yao Xie, Beijing Ditan Hospital
ClinicalTrials.gov Identifier:
NCT03210493
First received: July 3, 2017
Last updated: July 10, 2017
Last verified: July 2017
  Purpose
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, Treg cells Regulatory T cells played a negative role in immune. This study was aimed at investigating the changes of Treg cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α suppressed the virus, which led to the decline of Treg cells frequency and function;negative regulation of Tregs for immune cells diminished, hence, the function of immune cells recovered.

Condition Intervention
Chronic Hepatitis B Infection Drug: Peginterferon Alfa-2a

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Primary Purpose: Treatment
Official Title: The Changes of Treg Cells Frequency and Function During Pegylated Interferon α-2a and Nucleoside Analogues Treatment in Patients With Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Yao Xie, Beijing Ditan Hospital:

Primary Outcome Measures:
  • the changes of Treg Cells [ Time Frame: after treatment 24 weeks. ]
    Treg Cells will be measured by flow cytometry after Pegylated Interferon α-2a and entecavir(ETV) Treatment 24weeks.


Secondary Outcome Measures:
  • the change of HBVDNA levels (IU/ML) [ Time Frame: afte 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: afte treatment 48 weeks ]
    the curative effect of antiviral therapy will be evaluated by ALT levels

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

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

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


Estimated Enrollment: 120
Study Start Date: January 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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, Treg cells play an important role in immune regulation.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 Treg cells in the case of hepatitis and the function enhancement of Treg cells during Peg-IFN-α therapy. This study was aimed at investigating the changes of Treg cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α suppressed the virus, which led to the decline of Treg cells frequency and function;negative regulation of Tregs for immune cells diminished, hence, the function of immune cells recovered.
  Eligibility

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03210493

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

Locations
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

Responsible Party: Yao Xie, Head of liver diseases center, Beijing Ditan Hospital
ClinicalTrials.gov Identifier: NCT03210493     History of Changes
Other Study ID Numbers: DTXY015
Study First Received: July 3, 2017
Last Updated: July 10, 2017

Keywords provided by Yao Xie, Beijing Ditan Hospital:
chronic hepatitis B
hepatitis B virus
Treg Cells
Pegylated Interferon α-2a
Nucleoside Analogues

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Interferons
Peginterferon alfa-2a
Interferon-alpha
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 21, 2017