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

NCT07008755 | Recruiting

• 1 other identifier: IEC-C-007-A04
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

HFMD

Keywords

Peginterferon α-2b injection; HFMD

Outcome Measures

Primary Outcomes (4)

• Median time to resolution of fever

  Day5-7.

• Median time to resolution of skin rash

  Day5-7.

• Median time to resolution of oral ulcers

  Day5-7.

• Median time to resolution of feeding difficulties

  Day5-7.

Secondary Outcomes (23)

• Proportion of patients with complete recovery of fever

  Day 3

• Proportion of patients with complete recovery of fever

  Day 5

• Proportion of patients with complete recovery of rash

  Day 3

• Proportion of patients with complete recovery of rash

  Day 5

• Proportion of patients with complete recovery of oral ulcers

  Day 3

Study Arms (2)

Peginterferon α-2b 45 mcg dose group

EXPERIMENTAL

Drug: Peginterferon α-2b injection

Peginterferon α-2b 90 mcg dose group

EXPERIMENTAL

Drug: Peginterferon α-2b injection

Interventions

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 45 mcg dose group

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age: 1 year of age ≤ Age ≤ 6 years of age. 2.Gender: Both male and female. 3.Clinical symptoms/signs: Manifesting as common type HFMD (Stage 1, rash stage), with fever or rash symptoms first occurring within 72 hours prior to the signing of the informed consent form.
• Informed consent: Guardians understand and sign the informed consent form (if the guardian is the parent, both parents must sign).

You may not qualify if:

• (1) Severe or Critical HFMD Presentation at Enrollment
• Manifesting as severe HFMD (Stage 2, neurological involvement phase)
• Manifesting as critical HFMD (Stage 3 or 4, cardiopulmonary failure phase) with any of:
• Brainstem encephalitis, encephalomyelitis, or meningitis,Neurogenic pulmonary edema or respiratory failure requiring mechanical ventilation,Shock or circulatory collapse.
• Concurrent multi-organ failure requiring ICU monitoring
• (2) Allergy History and Treatment History
• <!-- -->
• Received interferon, ribavirin, acyclovir, ganciclovir, or vidarabine monophosphate within 30 days prior to screening or current use
• Received immunoglobulin or glucocorticoid therapy within 30 days prior to screening or current use
• Known hypersensitivity to interferon or its components, or other clinically significant allergies contraindicating participation
• Use of other investigational drugs within 3 months or 5 half-lives (whichever is longer) prior to screening, or current participation in medical device trials
• (3) Medical History
• <!-- -->
• Congenital heart disease, severe malnutrition, immune dysfunction, asthma, or other severe systemic diseases
• Active HBV, HCV, HIV, or Treponema pallidum infection

Sponsors & Collaborators

• Zhengzhou Children's Hospital, China: lead

Study Sites (5)

Xindu District People's Hospital of Chengdu

Chengdu, China

RECRUITING

The Seventh People's Hospital of Liangshan Yi Autonomous Prefecture

Liangshan, China

RECRUITING

Henan Children's Hospital (Zhengzhou Children's Hospital)

Zhengzhou, China

RECRUITING

Zhengzhou People's Hospital

Zhengzhou, China

RECRUITING

Ziyang Central Hospital

Ziyang, China

RECRUITING

Study Officials

• Fang Wang

  Henan Children's Hospital Zhengzhou Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Wang

CONTACT

13783637576; 13783637576@139.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: July 31, 2024
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-05

Locations

CN (5)