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Clinical Efficacy of Therapy with Recombinant Human Interferon alpha1b in Hand, Foot, and Mouth Disease with Enterovirus 71 Infection

Clinical Efficacy of Therapy with Recombinant Human Interferon alpha1b in Hand, Foot, and Mouth Disease with Enterovirus 71 Infection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14005153
Enrollment
Unknown
Registered
2014-08-28
Start date
2014-08-28
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hand foot and mouth disease

Interventions

ultrasonic aerosol inhalation group:supportive and symptomatic treatment+ inhaled ultrasonically nebulized rHuIFN-alpha1b (20ug freeze-dried powder of rHuIFN-alpha1b dissolved in 4ml physiological sa
intramuscular injection group:supportive and symptomatic treatment +rHuIFN-alpha1b (20ug freeze-dried powder of rHuIFN-alpha1b dissolved in 1ml physiological saline) by intramuscular injection
control group:supportive and symptomatic treatment

Sponsors

The First Affiliated hospital of Zhengzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 5 Years

Inclusion criteria

Inclusion criteria: Age from 0.5 to 5 years, according to the clinical diagnostice criteria fo HFMD, having one of followting clinical manifestations: 1. fever, axillary temperature higher than 38.5 degree; 2. neurological complications, including mental fatigue, irritability, headache, comiting, convalsions, limb weekness; 3. under rest state, respiratoty frequency(RF) more than 30, heart rate (HR)more than 140, and stool specimen was postive for EV71 by real-time RT-PCR.

Exclusion criteria

Exclusion criteria: 1. the critically HFMD patients,whose treatment was complicated by central respiratoy failure or who had brain-stem encephalitis, acute flaccid paralysis, neurogenic pulmonary edema, neurogenic shock or other severe symptoms and required endotracheal intubation and mechanical ventilation; 2. allergic constitution, especially allergic to multiple antibiotics or interferon products; 3. congenital heart diseas; 4. epilepsy and other central nervous system dysfuntion.

Design outcomes

Primary

MeasureTime frame
the time of temperature normalization;the time of skim rash disapparement;Change of the EV71 burden before and after treatment;Rate of temperature normalization;

Countries

China

Contacts

Public ContactSheng Guangyao
shenggy295@126.com+86 18665396029

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 2, 2026