The Changes of CD4+T Cells Frequency and Function During Antiviral Therapy
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|ClinicalTrials.gov Identifier: NCT03209011|
Recruitment Status : Unknown
Verified July 2017 by Yao Xie, Beijing Ditan Hospital.
Recruitment status was: Recruiting
First Posted : July 6, 2017
Last Update Posted : July 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Hepatitis B Infection||Drug: Peginterferon Alfa-2a||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Changes of CD4+T Cells Frequency and Function During Pegylated Interferon α-2a and Nucleoside Analogues Treatment in Patients With Chronic Hepatitis B|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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.
- the changes of CD4+T Cells [ Time Frame: at baseline and at treatment week 12, 24. ]the changes of CD4+T cells%, CD62L+T cells%, CD62L-T cells%, CD62L+/ CD62L-, CD69+CD4+T cells%, CD69MFI, CD69ABC, IFN-AR2+CD4+T cells%, IFNAR2MFI, IFNAR2ABC will be measured by flow cytometry during Pegylated Interferon α-2a and Nucleoside Analogues treatment every 3 months.
- the change of HBVDNA levels (IU/ML) [ Time Frame: at baseline and at treatment 12, 24, 36, 48 weeks ]the curative effect of antiviral therapy will be evaluated by HBV markers
- the change of ALT levels(U/L) [ Time Frame: at baseline and at treatment 12, 24, 36, 48 weeks ]the curative effect of antiviral therapy will be evaluated by ALT levels
- the change of AST levels(U/L) [ Time Frame: at baseline and at treatment 12, 24, 36, 48 weeks ]the curative effect of antiviral therapy will be evaluated by AST levels
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03209011
|Contact: Yao Xie, MDemail@example.com|
|Beijing Ditan hospital,Capital Medical University||Recruiting|
|Beijing, Beijing, China, 100015|
|Contact: Yao Xie, doctor 8613501093293 firstname.lastname@example.org|
|Principal Investigator: Yao Xie, doctor|