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Clinical Trial of Pegylated Interferon α-2b Via Nebulization for Treatment of Hand, Foot, and Mouth Disease .
Sponsor: Zhengzhou Children's Hospital, China
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.
Official title: Clinical Trial of Different Doses of Pegylated Interferon α-2b Injection Nebulization Therapy for Common Hand, Foot, and Mouth Disease (HFMD).
Key Details
Gender
All
Age Range
1 Year - 6 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2024-07-31
Completion Date
2027-12-31
Last Updated
2025-06-06
Healthy Volunteers
No
Conditions
Interventions
Peginterferon α-2b injection
During the study period, patients will continue to receive symptomatic supportive therapy, along with nebulized Peginterferon α-2b injection at a dose of 45 μg per administration, to be delivered on Day 1 and Day 3.
Peginterferon α-2b injection
CoDuring the study period, patients will continue to receive symptomatic supportive therapy, along with nebulized Peginterferon α-2b injection at a dose of 90 μg per administration, to be delivered on Day 1 and Day 3.
Locations (5)
Xindu District People's Hospital of Chengdu
Chengdu, China
The Seventh People's Hospital of Liangshan Yi Autonomous Prefecture
Liangshan, China
Henan Children's Hospital (Zhengzhou Children's Hospital)
Zhengzhou, China
Zhengzhou People's Hospital
Zhengzhou, China
Ziyang Central Hospital
Ziyang, China