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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03209037
Other study ID # DTXY014
Secondary ID
Status Recruiting
Phase Phase 4
First received June 30, 2017
Last updated July 10, 2017
Start date January 2016
Est. completion date December 2017

Study information

Verified date July 2017
Source Beijing Ditan Hospital
Contact Yao Xie, MD
Phone 8610-84322489
Email xieyao00120184@sina.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 20 Years to 60 Years
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
China Beijing Ditan hospital,Capital Medical University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Ditan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the changes of CD8+T Cells 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 a-2a and Nucleoside Analogues Treatment every 3 months. at baseline and at treatment week 12, 24.
Secondary the change of HBVDNA levels (IU/ML) the curative effect of antiviral therapy will be evaluated by HBV markers at baseline and at treatment 12, 24, 36, 48 weeks
Secondary the change of ALT levels(U/L) the curative effect of antiviral therapy will be evaluated by ALT levels at baseline and at treatment 12, 24, 36, 48 weeks
Secondary the change of AST levels(U/L) the curative effect of antiviral therapy will be evaluated by AST levels at baseline and at treatment 12, 24, 36, 48 weeks
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