NCT03209037

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, CD8+T cells are the main effector cells in adaptive immune response. This study was aimed at investigating the changes of CD8+T cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg-IFN-α suppressed the virus and the reduction of virus led to the recovery of CD8+T cells function, or Peg IFN - alpha enhanced CD8+T cells function which gave rise to the decline of the virus.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 6, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

July 12, 2017

Status Verified

July 1, 2017

Enrollment Period

1.9 years

First QC Date

June 30, 2017

Last Update Submit

July 10, 2017

Conditions

Chronic Hepatitis B Infection

Keywords

chronic hepatitis Bhepatitis B virusCD8+T CellsPegylated Interferon α-2aNucleoside Analogues

Outcome Measures

Primary Outcomes (1)

  • the changes of CD8+T Cells

    the changes of CD8+T cells%, CD69+CD8+T cells%, CD69MFI, CD69ABC, CD178+CD8+T cells%, CD178MFI, CD178ABC,IFN-AR2+CD8+T cells%, IFNAR2MFI, IFNAR2ABC will be measured by flow cytometry during Pegylated Interferon α-2a and Nucleoside Analogues Treatment every 3 months.

    at baseline and at treatment week 12, 24.

Secondary Outcomes (3)

  • the change of HBVDNA levels (IU/ML)

    at baseline and at treatment 12, 24, 36, 48 weeks

  • the change of ALT levels(U/L)

    at baseline and at treatment 12, 24, 36, 48 weeks

  • the change of AST levels(U/L)

    at baseline and at treatment 12, 24, 36, 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-2aDRUG

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

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Ditan hospital,Capital Medical University

Beijing, Beijing Municipality, 100015, China

RECRUITING

MeSH Terms

Conditions

Hepatitis B, ChronicHepatitis B

Interventions

peginterferon alfa-2a

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Yao Xie, MD

CONTACT

8610-84322489xieyao00120184@sina.com

Study Design

Study Type
interventional
Phase
phase 4
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

June 30, 2017

First Posted

July 6, 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)