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

Official title

Clinical Trial of Different Doses of Pegylated Interferon α-2b Injection Nebulization Therapy for Common Hand, Foot, and Mouth Disease (HFMD).

Overview

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.

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.

Primary outcome measures

• Median time to resolution of fever [Time frame: Day5-7.]
• Median time to resolution of skin rash [Time frame: Day5-7.]
• Median time to resolution of oral ulcers [Time frame: Day5-7.]
• Median time to resolution of feeding difficulties [Time frame: Day5-7.]

Secondary outcome measures (12)

• Proportion of patients with complete recovery of fever [Time frame: Day 3]
• Proportion of patients with complete recovery of fever [Time frame: Day 5]
• Proportion of patients with complete recovery of rash [Time frame: Day 3]
• Proportion of patients with complete recovery of rash [Time frame: Day 5]
• Proportion of patients with complete recovery of oral ulcers [Time frame: Day 3]
• Proportion of patients with complete recovery of oral ulcers [Time frame: Day 5]
• Proportion of patients with complete recovery of feeding difficulties [Time frame: Day 3]
• Proportion of patients with complete recovery of feeding difficulties [Time frame: Day 5]
• Proportion of patients showing improvement in fever [Time frame: Day 3]
• Proportion of patients showing improvement in fever [Time frame: Day 5]
• Proportion of patients showing improvement in rash [Time frame: Day 3]
• Proportion of patients showing improvement in rash [Time frame: Day 5]

Eligibility criteria

Inclusion criteria

-1. 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.

4.Informed consent: Guardians understand and sign the informed consent form (if the guardian is the parent, both parents must sign).

Exclusion criteria

• (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

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• 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

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• Congenital heart disease, severe malnutrition, immune dysfunction, asthma, or other severe systemic diseases
• Active HBV, HCV, HIV, or Treponema pallidum infection
• History of malignant tumors (current or prior)
• History of epilepsy, neurological/psychiatric disorders, or relevant family history

(4) Clinical Parameters: Resting respiratory rate >40 breaths/min,Heart rate >160 bpm

(5) Other Considerations: Any condition deemed by investigators to render participation medically inadvisable

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

China · 5 centers

• Xindu District People's Hospital of Chengdu — Chengdu
• The Seventh People's Hospital of Liangshan Yi Autonomous Prefecture — Liangshan
• Henan Children's Hospital (Zhengzhou Children's Hospital) — Zhengzhou
• Zhengzhou People's Hospital — Zhengzhou
• Ziyang Central Hospital — Ziyang

Identifiers

NCT: NCT07008755 · IEC-C-007-A04

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗