NCT07008755招募中不适用
Clinical Trial of Different Doses of Pegylated Interferon α-2b Injection Nebulization Therapy for Common Hand, Foot, and Mouth Disease (HFMD).
Zhengzhou Children's Hospital, China5 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2024年7月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- Median time to resolution of fever
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •(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
- •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
研究组 & 干预措施
Peginterferon α-2b 45 mcg dose group
Experimental
干预措施: Peginterferon α-2b injection (Drug)
Peginterferon α-2b 90 mcg dose group
Experimental
干预措施: Peginterferon α-2b injection (Drug)
结局指标
主要结局
Median time to resolution of fever
时间窗: Day5-7.
Median time to resolution of skin rash
时间窗: Day5-7.
Median time to resolution of oral ulcers
时间窗: Day5-7.
Median time to resolution of feeding difficulties
时间窗: Day5-7.
次要结局
- Proportion of patients developing pulmonary edema(Day1-7)
- Proportion of patients developing myocarditis(Day1-7)
- Proportion of patients developing respiratory failure(Day1-7)
- Proportion of patients developing circulatory failure(Day1-7)
- Proportion of patients developing meningoencephalitis(Day1-7)
- Proportion of patients achieving viral nucleic acid negativity(Day 5)
- Proportion of patients with complete recovery of rash(Day 5)
- Proportion of patients with complete recovery of fever(Day 5)
- Proportion of patients with complete recovery of oral ulcers(Day 5)
- Proportion of patients with complete recovery of feeding difficulties(Day 5)
- Proportion of patients showing improvement in fever(Day 5)
- Proportion of patients showing improvement in rash(Day 5)
- Proportion of patients showing improvement in oral ulcers(Day 5)
- Proportion of patients showing improvement in feeding difficulties(Day 5)
研究者
Fang Wang
Chief physician
Zhengzhou Children's Hospital, China
研究点 (5)
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