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

• Status: Completed
• Trial end date: 2018-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Fudan University
• Collaborators: Anhui Provincial Children's Hospital; Changhai Hospital; Children's Hospital of Chongqing Medical University; Children's Hospital of Kaifeng City; Hunan Children's Hospital; Qilu Children's Hospital of Shandong University; Shenzhen Children's Hospital; Tianjin Sinobioway Biomedicine Co.Ltd.; Yuying Children's Hospital of Wenzhou Medical University; Zunyi Medical College
• Treatments: Interferon-alpha; Interferons; Ribavirin

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.