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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Peginterferon α-2b injection

    Drug

    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

    Drug

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Peginterferon α-2b 45 mcg dose groupExperimental treatment 1 intervention
Group B: Peginterferon α-2b 90 mcg dose groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Median time to resolution of fever

Time frame
Day5-7.
2

Median time to resolution of skin rash

Time frame
Day5-7.
3

Median time to resolution of oral ulcers

Time frame
Day5-7.
4

Median time to resolution of feeding difficulties

Time frame
Day5-7.

Secondary outcomes

1

Proportion of patients with complete recovery of fever

Time frame
Day 3
2

Proportion of patients with complete recovery of fever

Time frame
Day 5
3

Proportion of patients with complete recovery of rash

Time frame
Day 3
4

Proportion of patients with complete recovery of rash

Time frame
Day 5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhengzhou Children's Hospital, China

Lead sponsor

Source ClinicalTrials.gov
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