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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03210506
Other study ID # DTXY016
Secondary ID
Status Recruiting
Phase N/A
First received July 3, 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, cytokines played a vital role. This study was aimed at investigating the changes of cytokines during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to verify whether Peg-IFN-α therapy resulted in the secretion of cytokines.


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, cytokines including Fit-3L, IFN-alpha2, IFN-gama, IL-10, IL-17A,IL-2, IL-6, TNF-alpha, TGF-beta1, TGF-beta2,TGF-beta3, played a vital role.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 might be related to the increase of cytokine secretion in the case of hepatitis and during Peg-IFN-α therapy.This study was aimed at investigating the changes of cytokines during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators wanted to clarify whether Peg-IFN-α therapy led to the secretion of cytokines.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
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 cytokines the changes of cytokines levels will be measured by Luminex test after Pegylated Interferon a-2a and entecavir((ETV) Treatment 24 weeks. after treatment 24 weeks
Secondary the change of HBVDNA levels (IU/ML) the curative effect of antiviral therapy will be evaluated by HBV DNA levels afte treatment 48 weeks
Secondary the change of ALT levels(U/L) the curative effect of antiviral therapy will be evaluated by ALT levels afte treatment 48 weeks
Secondary the change of AST levels(U/L) the curative effect of antiviral therapy will be evaluated by AST levels afte treatment 48 weeks
Secondary the change of HBsAg levels (IU/ML) the curative effect of antiviral therapy will be evaluated by HBsAg levels afte treatment 48 weeks
Secondary the change of HBeAg levels (IU/ML) the curative effect of antiviral therapy will be evaluated by HBeAg levels afte treatment 48 weeks
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