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Peginterferon α-2b Injection for the Treatment of Pediatric RSV Bronchiolitis
Sponsor: Children's Hospital of Soochow University
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.
Official title: 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
Key Details
Gender
All
Age Range
6 Months - 2 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2025-03
Completion Date
2027-06
Last Updated
2025-02-14
Healthy Volunteers
No
Conditions
Interventions
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.
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.
Locations (3)
Wuhan Women and Children's Health Care Center
Wuhan, Hubei, China
Children's Hospital of Soochow University
Suzhou, Jiangsu, China
The First Hospital of Jilin University
Changchun, Jilin, China