Clinical Trial of Pegylated Interferon α-2b Via Nebulization for Treatment of Hand, Foot, and Mou… (NCT07008755) | Clinical Trial Compass
RecruitingNot Applicable
Clinical Trial of Pegylated Interferon α-2b Via Nebulization for Treatment of Hand, Foot, and Mouth Disease .
China90 participantsStarted 2024-07-31
Plain-language 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.
Who can participate
Age range1 Year – 6 Years
SexALL
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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.
✓.Informed consent: Guardians understand and sign the informed consent form (if the guardian is the parent, both parents must sign).
Exclusion criteria
✕. Manifesting as severe HFMD (Stage 2, neurological involvement phase)
✕. Manifesting as critical HFMD (Stage 3 or 4, cardiopulmonary failure phase) with any of:
✕. 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
✕. Congenital heart disease, severe malnutrition, immune dysfunction, asthma, or other severe systemic diseases