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Peginterferon α-2b Injection for the Treatment of Pediatric RSV Bronchiolitis

NCT06827249 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-02-14

No results posted yet for this study

Summary

This is a multicenter, randomized, positive-controlled, non-inferiority clinical study, planning to enroll 90 children with bronchiolitis caused by respiratory syncytial virus infection, to evaluate the safety and efficacy of inhaled Peginterferon α-2b injection compared to recombinant human interferon α2b in the treatment of pediatric respiratory syncytial virus bronchiolitis.

Conditions

  • Bronchiolitis

Interventions

DRUG

Peginterferon α-2b injection

Peginterferon α-2b injection, 90 mcg, on the basis of conventional treatments such as asthma control, oxygen inhalation, and fluid replacement, nebulized inhalation using air compression or oxygen-driven methods is administered on days 1, 3, and 5, once a day.

DRUG

Recombinant Human Interferon α2b

Recombinant Human Interferon alpha 2b, at a dose of 100,000 IU/kg, based on the conventional treatments such as asthma control, oxygen inhalation, and fluid replacement, will be administered via nebulized inhalation using air compression or oxygen-driven methods from day 1 to day 5, twice daily.

Sponsors & Collaborators

  • Children's Hospital of Soochow University

    lead OTHER

Principal Investigators

  • Chuangli Hao, Ph.D · Children's Hospital of Soochow University

  • Fanzheng Meng, Ph.D · The First Hospital of Jilin University

  • Xiaoxia Lu, Ph.D · Wuhan women and children's health care center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
6 Months
Max Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-31
Primary Completion
2026-06-30
Completion
2027-06-30

Countries

  • China

Study Locations

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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 NCT06827249 on ClinicalTrials.gov