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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03210467
Other study ID # DTXY011
Secondary ID
Status Recruiting
Phase N/A
First received June 30, 2017
Last updated July 4, 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 Observational

Clinical Trial Summary

Pegylated interferon(IFN) α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while entecavir(ETV) drugs only inhibit viral replication. In hepatitis B infection, Plasmacytoid Dendritic Cells(pDCs) are the main effector cells in early antiviral innate immune response. This study was aimed at investigating the changes of pDCs frequency and function, and the expression of costimulatory molecules CD86(Cluster of Differentiation antigen 86) during Peg-IFN-αand entecavir(ETV) therapy.Meanwhile, investigators want to verify whether Peg-IFN-α suppressed the virus and the reduction of virus led to the recovery of pDCs function, or Peg-IFN-α enhanced pDCs function which gave rise to the decline of the virus.


Description:

Pegylated interferon α-2a(Peg-IFN-α)and entecavir(ETV) drugs can inhibit viral replication , but Peg-IFN-α also play an important role in immune regulation . In hepatitis B infection, Plasmacytoid Dendritic Cells (pDCs) are the main effector cells in early antiviral innate immune response.Peg-IFN-α recommended as the first-line treatment has a higher chance to achieve HBeAg seroconversion and even HBsAg disappearance than entecavir(ETV) drugs, which may be related to the functional activation of pDCs in the case of hepatitis and the function enhancement of pDCs during Peg-IFN-α therapy. This study was aimed at investigating the changes of pDCs frequency and function, and the expression of costimulatory molecules CD86 during Peg-IFN-αandentecavir(ETV) therapy.Meanwhile,investigators want to explore whether the decline of HBsAg and HBeAg resulted in recovery of CD86+pDC function, or recovery of CD86 + pDC function led to the decrease of HBsAg and HBeAg. Several studies demonstrated that HBsAg and HBeAg could damage pDC function, and the loss of HBsAg and HBeAg led to recovery of CD86+pDC function.


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, HBVDNA detectable with ALT(alanine aminotransferase) 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


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 change of pDC% The host immune function will be evaluated by pDC. pDC% will be measured by flow cytometry after Pegylated Interferon a-2a and entecavir(ETV) Treatment 24 weeks. after treatment 24 weeks
Primary the change of CD86+pDC% CD86+pDC% will be measured by flow cytometry after Pegylated Interferon a-2a and entecavir(ETV) Treatment 24 weeks. after treatment 24 weeks
Primary the change of mean fluorescence intensity of costimulatory molecules CD86(CD86-MFI) mean fluorescence intensity of costimulatory molecules CD86(CD86-MFI) will be measured by flow cytometry after Pegylated Interferon a-2a and entecavir(ETV) Treatment 24 weeks. after treatment 24 weeks
Primary the change of absolute molecular counting of costimulatory molecules CD86 absolute molecular counting of costimulatory molecules CD86 (CD86-ABC) will be measured by flow cytometry 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 after treatment 48 weeks
Secondary the change of ALT levels(U/L) the curative effect of antiviral therapy will be evaluated by ALT levels after treatment 48 weeks
Secondary the change of AST levels(U/L) the curative effect of antiviral therapy will be evaluated by AST levels after treatment 48 weeks
Secondary the change of HBsAg levels (IU/ML) the curative effect of antiviral therapy will be evaluated by HBsAg levels after treatment 48 weeks
Secondary the change of HBeAg levels (IU/ML) the curative effect of antiviral therapy will be evaluated by HBeAg levels after treatment 48 weeks
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