NCT03771677

Brief Summary

The study is to guide clinical cure of peginterferon alfa-2a treatment in patients with chronic hepatitis B based on the detection of interferon gene mutation (IFNA2p.Ala120Thr) and interferon-stimulated genes (ISGs) detection gene spectrum.

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
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

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

December 1, 2018

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

May 8, 2023

Status Verified

May 1, 2023

Enrollment Period

5.1 years

First QC Date

December 8, 2018

Last Update Submit

May 4, 2023

Conditions

Hepatitis B

Keywords

Chronic Hepatitis BIFNA2p.Ala120Thr /ISGs

Outcome Measures

Primary Outcomes (1)

  • HBsAg clearance rate

    Whether the HBsAg clearance rate of patients who received interferon treatment was higher than those treated with nucleoside drugs.

    48 weeks

Secondary Outcomes (1)

  • HBV cccDNA and pgRNA quantification dynamic change

    48 weeks

Study Arms (2)

Active Comparator:NAs group

ACTIVE COMPARATOR

Active Comparator:nucleotide analogues(NAs) patients continue to use NAs

Drug: Nucleotide Analog

Experimental:PEG-IFN group

EXPERIMENTAL

Experimental: peg-interferon alfa-2a patients use peg-interferon α-2a and nucleotide analogues(NAs)

Drug: Nucleotide AnalogDrug: Interferon Alfa-2A

Interventions

Nucleotide AnalogDRUG

such as Entecavir,entecavir 0.5mg per day

Also known as: Nucleotide Analogs
Active Comparator:NAs groupExperimental:PEG-IFN group
Interferon Alfa-2ADRUG

Peginterferon alfa-2a 180ug per week

Also known as: Pegasys
Experimental:PEG-IFN group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 60 years old;
  • HBsAg positive, HBsAg quantification≤1500 IU/mL;
  • Serum HBV DNA quantification \<100 IU/mL;
  • HBeAg negative.

You may not qualify if:

  • Treated with interferon in the past six months;
  • Liver cirrhosis or HCC and other associated tumors;
  • Women during pregnancy or lactation;
  • With liver disease caused by other causes;
  • Combination infection of HIV or other immunodeficiency diseases;
  • With diabetes, autoimmune diseases and other organ dysfunction or failure;
  • Combination of other serious complications (infection, hepatic encephalopathy,gastrointestinal bleeding, hepatorenal syndrome, etc.);
  • Others who cannot be treated with interferon;
  • Anyone cannot return to the hospital for follow-up and follow-up visits regularly as planned

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chan Xie

Guangzhou, Guangdong, 510000, China

RECRUITING

MeSH Terms

Conditions

Hepatitis BHepatitis B, Chronic

Interventions

NucleotidesInterferon alpha-2peginterferon alfa-2a

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

GlycosidesCarbohydratesNucleic Acids, Nucleotides, and NucleosidesInterferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Chan Xie

    The Third Affliated Hospital of Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chan Xie, Professor

CONTACT

862085252043happyxiechan@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
Active Comparator:nucleotide analogues(NAs) patients continue to use NAs Experimental: peg-interferon alfa-2a patients switch to sequential peg-interferon α-2a
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Drug: nucleotide analogues(NAs) Drug: Peginterferon alfa-2a and nucleotide analogues(NAs)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of department of infectious disease Third Affiliated Hospital,Sun Yat-Sen University

Study Record Dates

First Submitted

December 8, 2018

First Posted

December 11, 2018

Study Start

December 1, 2018

Primary Completion

December 30, 2023

Study Completion

December 30, 2024

Last Updated

May 8, 2023

Record last verified: 2023-05

Locations

CN(1)