NCT04028856

Brief Summary

This study was a retrospective clinical observational cohort study. All patients with chronic hepatitis B (CHB) whose HBsAg decreased by less than 10% were treated continuously with interferon in the Department of Hepatology, Beijing Ditan Hospital, Beijing Medical University, Beijing Capital University, 2008.10-2017.4. The total interferon treatment time of the enrolled subjects was 48 weeks. The subjects were randomly divided into the following two observation cohorts: 1) patients with chronic hepatitis B treated with continuous interferon for 48 weeks; 2) intermittent interferon For 48 weeks of treatment for patients with chronic hepatitis B, the interferon treatment interval was 3 months. HBV DNA content, HBsAg/anti-HBs, HBeAg/anti-HBe and biochemical markers, serum AFP and liver imaging (liver ultrasound) were collected before treatment (baseline) and during treatment. The primary outcome measure was the rate at which HBsAg disappeared at 48 weeks of treatment. The secondary evaluation index was the 48-week HBeAg seroconversion rate. To investigate the efficacy, influencing factors and safety of interferon intermittent treatment of chronic hepatitis B.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2019

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2019

Completed
Last Updated

July 23, 2019

Status Verified

July 1, 2019

Enrollment Period

1.1 years

First QC Date

July 20, 2019

Last Update Submit

July 20, 2019

Conditions

Chronic Hepatitis B

Keywords

Chronic hepatitis BinterferonintermittentHBVHBsAgHBV DNA

Outcome Measures

Primary Outcomes (1)

  • Rate of disappearance of HBsAg

    Rate of disappearance of HBsAg after 48 weeks of treatment

    after 48 weeks of treatment

Secondary Outcomes (1)

  • HBeAg seroconversion rate

    at the treatment of 48 weeks

Study Arms (2)

Continuous interferon treatment group

Patients with chronic hepatitis B treated with continuous interferon for 48 weeks

Drug: interferon

Intermittent interferon treatment group

patients with chronic hepatitis B treated with intermittent interferon for 48 weeks, in which interferon therapy was intermittent for 3 months

Drug: interferon

Interventions

interferonDRUG

Chronic hepatitis B patients were treated with interferon for 48 weeks

Continuous interferon treatment groupIntermittent interferon treatment group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chronic hepatitis B (CHB) with a reduction in HBsAg of less than 10% were treated with interferon for 6 months. All patients with chronic hepatitis B were eligible for the diagnostic criteria of the Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015).

You may qualify if:

  • All patients with chronic hepatitis B meet the diagnostic criteria of China Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2015)

You may not qualify if:

  • coinfection with other viruses including HCV, HDV, and HIV;
  • syphilis antibody positive;
  • co-exist other liver diseases including alcoholic liver disease, metabolic liver disease, fatty liver, drug induce liver injury, and autoimmune liver disease;
  • complication of cirrhosis or liver cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

liver disease center, Beijing Ditan Hospital

Beijing, Beijing Municipality, 100015, China

Location

Related Publications (1)

  • Li M, Xie S, Bi X, Sun F, Zeng Z, Deng W, Jiang T, Lin Y, Yang L, Lu Y, Zhang L, Yi W, Xie Y. An optimized mode of interferon intermittent therapy help improve HBsAg disappearance in chronic hepatitis B patients. Front Microbiol. 2022 Aug 30;13:960589. doi: 10.3389/fmicb.2022.960589. eCollection 2022.

    PMID: 36110295DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Interferons

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

CytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological Factors

Study Officials

  • Yao Xie, Doctor

    Department of hepatology Division 2, Beijing Ditan Hospital, Capital Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of liver diseases center

Study Record Dates

First Submitted

July 20, 2019

First Posted

July 23, 2019

Study Start

June 1, 2018

Primary Completion

June 30, 2019

Study Completion

June 30, 2019

Last Updated

July 23, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)