MedTrace Logo

Efficacy of NA Combined With PEG-IFN-α2b in the Continuous Versus Pulsed Treatment of Patients With Chronic Hepatitis B

NCT05922306 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 1084

Last updated 2023-06-28

No results posted yet for this study

Summary

Previous studies have shown that there are alterations in the number and affinity of interferon receptors during interferon therapy and that such alterations recover to varying degrees some time after the end of treatment. It can be conjectured that the rest period of pulsed therapy facilitates the recovery of type I interferon receptors and thus the next round of IFN therapy compared to a continuous regimen of interferon.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

PEGylated recombinant human interferon alpha-2b injection

Continuous combination therapy: pegylated interferon alpha-2b 180µg, subcutaneously once a week for 96 weeks, combined with NAs throughout the treatment period.

DRUG

PEGylated recombinant human interferon alpha-2b injection

Pulsed combination therapy: pegylated interferon alpha-2b 180µg once weekly by subcutaneous injection for 8 weeks with 4 weeks off for a total treatment duration of 96 weeks, combined with NAs throughout the treatment period.

Sponsors & Collaborators

  • The First Affiliated Hospital, University of Science and Technology of China

    collaborator OTHER

  • The Second Hospital of Anhui Medical University

    collaborator OTHER

  • Chaohu Hospital of Anhui Medical University

    collaborator OTHER

  • The First Affiliated Hospital of Bengbu Medical University

    collaborator OTHER

  • Anhui Medical University

    lead OTHER

Principal Investigators

  • Jiabing Li, MD · The First Affiliated Hospital of Anhui Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2027-06-30
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05922306 on ClinicalTrials.gov