Clinical trial NCT03266601: Effect of Recombinant Human Interferon α-2b Spray on Herpangina
Official title: Effect and Safety of Recombinant Human Interferon α-2b Spray on Herpangina in Pediatric Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Herpangina
Keywords: Aged 1-7 years old, within 72 hours of onset patients with herpangina
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
Collaborators: name: Tianjin Sinobioway Biomedicine Co.Ltd.
name: Hunan Children's Hospital
name: Children's Hospital of Chongqing Medical University
name: Yuying Children's Hospital of Wenzhou Medical University
name: Qilu Children's Hospital of Shandong University
name: Children's Hospital of Kaifeng City
name: Shenzhen Children's Hospital
name: Zunyi Medical College
name: Changhai Hospital
name: Anhui Provincial Children's Hospital
First posted: 2017-08-30
Enrollment: 668
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, open，randomized controlled trial aiming to evaluate the effectiveness of recombinant human interferon α-2b spray compared with ribavirin treatment on pediatric patients with herpangina.


Eligibility criteria: Inclusion Criteria:

Subjects should meet all of the following:

1. meet the diagnostic criteria for pediatric herpangina;
2. ages 1-7 years, no limitation for gender;
3. within 72 hours of onset;
4. the main organs (heart, liver, kidney and lung) function normally;
5. follow up according to requirements and be hospitalized for observation;
6. the guardian is fully informed and signed informed consent.

Exclusion Criteria:

Subjects should be excluded if meet any of the following:

1. have allergy history of interferon;
2. heart failure, respiratory insufficiency,liver and kidney dysfunction or severe malnutrition and other serious disease, or immunodeficient;
3. children with epilepsy or other neurological disorders;
4. other pathogens exist at the same time;
5. the researchers believe that it is not appropriate to participate in this study.

Primary outcomes:
measure: The defervesce rate during treatment by 72 hours
timeFrame: Measure the body temperature every 4 hours from starting of treatment to the 96th hour.
Secondary outcomes:
measure: Abnormal blood routine
timeFrame: Before admission and 72th hours after treatment.
measure: The significant efficiency rate
timeFrame: From starting of treatment to the 48th hour.
measure: The effective rate
timeFrame: From starting of treatment to the 72th hour.
measure: The ineffective rate
timeFrame: From starting of treatment to the 96th hour.
measure: The total effective rate
timeFrame: From starting of treatment to the 96th hour.
measure: Total hospital stay
timeFrame: From starting of treatment to the 96th hour.
measure: Appetite improvement
timeFrame: From starting of treatment to the 96th hour.
measure: Myocardial enzymes and electrocardiogram
timeFrame: Before admission and 72th hours after treatment.
measure: The condition of herpes and ulcers subside
timeFrame: Check the oral herpes or ulcers subsided every 24 hours from starting of treatment to the 72th hour.
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
Study officials:
References: