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

ConditionHFMD
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-6
SponsorZhengzhou Children's Hospital, China

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

(1) Severe or Critical HFMD Presentation at Enrollment

Manifesting as severe HFMD (Stage 2, neurological involvement phase)

Concurrent multi-organ failure requiring ICU monitoring

Received interferon, ribavirin, acyclovir, ganciclovir, or vidarabine monophosphate within 30 days prior to screening or current use

Trial design

Treatments tested in this trial

  • Peginterferon α-2b injection
  • Peginterferon α-2b injection

Treatment groups

90 Participants
are divided into 2 treatment groups