Effect of Recombinant Human Interferon α-2b Spray on Herpangina

Fudan University

Status and phase: Completed; Phase 4

Conditions: Herpangina

Treatments: Drug: Recombinant Human Interferon α-2b Spray; Drug: Ribavirin

Study type: Interventional

Funder types: Other

Identifiers

NCT03266601

AFL-2015-2.0

Details and patient eligibility

About

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.

Enrollment: 668 patients

Sex: All

Ages: 1 to 7 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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668 participants in 2 patient groups

Recombinant Human Interferon α-2b Spray

Experimental group

Treatment:

Drug: Recombinant Human Interferon α-2b Spray

Ribavirin

Active Comparator group

Treatment:

Drug: Ribavirin