The Changes of Plasmacytoid Dendritic Cells Frequency and Function During Antiviral Therapy

Chronic Hepatitis B Infection Clinical Trial

Official title:

The Changes of Plasmacytoid Dendritic Cells Frequency and Function During Pegylated Interferon α-2a and Entecavir(ETV) Treatment in Patients With Chronic Hepatitis B.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03210467
• Other study ID #: DTXY011
• 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
• 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

Related Conditions & MeSH terms

• Chronic Hepatitis B Infection
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

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