The Changes of Cytokines During Antiviral Therapy

NCT03210506 | Unknown

• 1 other identifier: DTXY016
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis B Infection

Keywords

chronic hepatitis B; hepatitis B virus; Cytokines; Pegylated Interferon α-2a; Nucleoside Analogues

Outcome Measures

Primary Outcomes (1)

• the changes of cytokines

  the changes of cytokines levels will be measured by Luminex test after Pegylated Interferon α-2a and entecavir((ETV) Treatment 24 weeks.

  after treatment 24 weeks

Secondary Outcomes (5)

• the change of HBVDNA levels (IU/ML)

  afte treatment 48 weeks

• the change of ALT levels(U/L)

  afte treatment 48 weeks

• the change of AST levels(U/L)

  afte treatment 48 weeks

• the change of HBsAg levels (IU/ML)

  afte treatment 48 weeks

• the change of HBeAg levels (IU/ML)

  afte treatment 48 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

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

control group

NO INTERVENTION

patients who were untreated ever in immune-active phase took Nucleoside Analogues for maintenance treatment.

Interventions

Peginterferon Alfa-2a DRUG

patients untreated in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly in experiment group.

Also known as: Peg-IFN-α

experimental group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Ditan Hospital: lead

Study Sites (1)

Beijing Ditan hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yao Xie, MD

CONTACT

8610-84322489; xieyao00120184@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of liver diseases center

Study Record Dates

• First Submitted: July 3, 2017
• First Posted: July 7, 2017
• Study Start: January 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

CN (1)