drugset / Trial / NCT07008755

Clinical Trial of Pegylated Interferon α-2b Via Nebulization for Treatment of Hand, Foot, and Mouth Disease .

NCT07008755

Recruiting 90 enrolled Zhengzhou Children's Hospital, China
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a multicenter clinical trial investigating the safety and efficacy of inhaled Peginterferon α-2b at different doses, in combination with supportive care, for the treatment of patients with hand, foot, and mouth disease (HFMD) of ordinary type. The trial aims to enroll 90 patients with HFMD. Eligible subjects will be randomly assigned to receive either supportive care + Peginterferon α-2b mcg or supportive care + Peginterferon α-2b 90 mcg, administered on days 1 and 3. The study period includes a 3-day screening phase and a 5-7 day inpatient visit period. The results of this trial will be used to evaluate safety and efficacy.

Timeline

Start
2024-07-31
Primary completion
2027-10-31
Completion
2027-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon α-2b Protein / enzyme biologic 45 ug Inhaled
Subject Peginterferon α-2b Protein / enzyme biologic 90 ug Inhaled