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RECRUITING
NCT07008755
NA

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

Sponsor: Zhengzhou Children's Hospital, China

View on ClinicalTrials.gov

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

DRUG

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.

DRUG

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