Completed

Effect and Safety of Recombinant Human Interferon α-2b Spray on Herpangina in Pediatric Patients

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What is being tested

Recombinant Human Interferon α-2b Spray

+ Ribavirin

Drug
Who is being recruted

Coxsackievirus Infections+5

+ Echovirus Infections

+ Enterovirus Infections

From 1 to 7 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: June 2016
See protocol details

Summary

Principal SponsorChildren's Hospital of Fudan University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 1, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleEffect and Safety of Recombinant Human Interferon α-2b Spray on Herpangina in Pediatric Patients
NCT03266601
Principal SponsorChildren's Hospital of Fudan University
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

668 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 7 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Coxsackievirus InfectionsEchovirus InfectionsEnterovirus InfectionsHerpanginaInfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus Diseases

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Children's Hospital of Fudan University

Shanghai, ChinaOpen Children's Hospital of Fudan University in Google Maps
CompletedOne Study Center