HFMDNCT07008755
Clinical Trial of Pegylated Interferon α-2b Via Nebulization for Treatment of Hand, Foot, and Mouth Disease .
A study testing Peginterferon α-2b injection in people with HFMD, run by Zhengzhou Children's Hospital, China at 5 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- HFMD
- What is being tested?
- Peginterferon α-2b injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 5 sitesChina
- Study dates
- 31 Jul 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- -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).
Who cannot join
- (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
- Allergy History and Treatment History
Show all 19Show fewer
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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
- 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
- Clinical Parameters: Resting respiratory rate >40 breaths/min,Heart rate >160 bpm
- Other Considerations: Any condition deemed by investigators to render participation medically inadvisable
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Xindu District People's Hospital of Chengdu
Chengdu
Jingrong Yang
- Recruiting
The Seventh People's Hospital of Liangshan Yi Autonomous Prefecture
Liangshan
Min Fang
- Recruiting
Henan Children's Hospital (Zhengzhou Children's Hospital)
Zhengzhou
Fang Wang
- Recruiting
Zhengzhou People's Hospital
Zhengzhou
Chao Liu
- Recruiting
Ziyang Central Hospital
Ziyang
Jing Tang
About this study
Official title: Clinical Trial of Different Doses of Pegylated Interferon α-2b Injection Nebulization Therapy for Common Hand, Foot, and Mouth Disease (HFMD).
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
- Being tested
- Peginterferon α-2b injection
- Keywords
- Peginterferon α-2b injection, HFMD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon α-2b injectionDrug
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 injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon α-2b 45 mcg dose group | Experimental | Not described Receives: Drug: Peginterferon α-2b injection |
| Peginterferon α-2b 90 mcg dose group | Experimental | Not described Receives: Drug: Peginterferon α-2b injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median time to resolution of fever
Measured: Day5-7.
Median time to resolution of skin rash
Measured: Day5-7.
Median time to resolution of oral ulcers
Measured: Day5-7.
Median time to resolution of feeding difficulties
Measured: Day5-7.
Secondary outcomes (23)
Proportion of patients with complete recovery of fever
Measured: Day 3
Proportion of patients with complete recovery of fever
Measured: Day 5
Proportion of patients with complete recovery of rash
Measured: Day 3
Proportion of patients with complete recovery of rash
Measured: Day 5
Proportion of patients with complete recovery of oral ulcers
Measured: Day 3
Proportion of patients with complete recovery of oral ulcers
Measured: Day 5
Proportion of patients with complete recovery of feeding difficulties
Measured: Day 3
Proportion of patients with complete recovery of feeding difficulties
Measured: Day 5
Proportion of patients showing improvement in fever
Measured: Day 3
Proportion of patients showing improvement in fever
Measured: Day 5
Proportion of patients showing improvement in rash
Measured: Day 3
Proportion of patients showing improvement in rash
Measured: Day 5
Proportion of patients showing improvement in oral ulcers
Measured: Day 3
Proportion of patients showing improvement in oral ulcers
Measured: Day 5
Proportion of patients showing improvement in feeding difficulties
Measured: Day 3
Proportion of patients showing improvement in feeding difficulties
Measured: Day 5
Proportion of patients developing pulmonary edema
Measured: Day1-7
Proportion of patients developing myocarditis
Measured: Day1-7
Proportion of patients developing respiratory failure
Measured: Day1-7
Proportion of patients developing circulatory failure
Measured: Day1-7
Proportion of patients developing meningoencephalitis
Measured: Day1-7
Proportion of patients achieving viral nucleic acid negativity
Measured: Day 3
Proportion of patients achieving viral nucleic acid negativity
Measured: Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start31 Jul 2024
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HFMDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhengzhou Children's Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang Wang, Zhengzhou Children's Hospital, China
- Investigators
- Fang Wang, Principal investigator, Zhengzhou Children's Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008755
- Sponsor's protocol ID
- IEC-C-007-A04
- Status last verified
- May 2025
- First submitted
- 29 May 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of Different Doses of Pegylated Interferon α-2b Injection Nebulization Therapy for Common Hand, Foot, and Mouth Disease (HFMD).
- ClinicalTrials.gov ID
- NCT07008755
- Acronym / sponsor ID
- IEC-C-007-A04
- Conditions
- HFMD
- Keywords
- Peginterferon α-2b injection, HFMD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Zhengzhou Children's Hospital, ChinaUniversity, hospital or other
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 6 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- -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).
Key exclusion criteria (19 listed)
- (1) Severe or Critical HFMD Presentation at Enrollment
- Brainstem encephalitis, encephalomyelitis, or meningitis,Neurogenic pulmonary edema or respiratory failure requiring mechanical ventilation,Shock or circulatory collapse.
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Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon α-2b injectionDuring 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 45 mcg dose group |
| Peginterferon α-2b injectionCoDuring 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. | Drug | Peginterferon α-2b 90 mcg dose group |
Primary outcome
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.
23 secondary outcomes
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
Proportion of patients showing improvement in oral ulcers
Time frame: Day 3
Proportion of patients showing improvement in oral ulcers
Time frame: Day 5
Proportion of patients showing improvement in feeding difficulties
Time frame: Day 3
Proportion of patients showing improvement in feeding difficulties
Time frame: Day 5
Proportion of patients developing pulmonary edema
Time frame: Day1-7
Proportion of patients developing myocarditis
Time frame: Day1-7
Proportion of patients developing respiratory failure
Time frame: Day1-7
Proportion of patients developing circulatory failure
Time frame: Day1-7
Proportion of patients developing meningoencephalitis
Time frame: Day1-7
Proportion of patients achieving viral nucleic acid negativity
Time frame: Day 3
Proportion of patients achieving viral nucleic acid negativity
Time frame: Day 5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Fang Wang principal investigator
Zhengzhou Children's Hospital, China
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peginterferon α-2b injection in people with HFMD, run by Zhengzhou Children's Hospital, China at 5 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang Wang (13783637576, 13783637576@139.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median time to resolution of fever (time frame: Day5-7.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.