NCT06827249

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

A Multicenter, Randomized, Positive-controlled, Non-inferiority Clinical Study to Evaluate the Safety and Efficacy of Peginterferon α2b Injection in the Treatment of Pediatric RSV Bronchiolitis

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Children's Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 6 Months – 2 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2025-03-01
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2025-02-14
• Last updated: 2025-02-14

Locations

3 sites across 1 country: China