Status:

COMPLETED

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

Lead Sponsor:

Children's Hospital of Fudan University

Collaborating Sponsors:

Tianjin Sinobioway Biomedicine Co.Ltd.

Hunan Children's Hospital

Conditions:

Herpangina

Eligibility:

All Genders

1-7 years

Phase:

PHASE4

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 her...

Eligibility Criteria

Inclusion

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

Exclusion

  • Subjects should be excluded if meet any of the following:
  • have allergy history of interferon;
  • heart failure, respiratory insufficiency,liver and kidney dysfunction or severe malnutrition and other serious disease, or immunodeficient;
  • children with epilepsy or other neurological disorders;
  • other pathogens exist at the same time;
  • the researchers believe that it is not appropriate to participate in this study.

Key Trial Info

Start Date :

June 1 2016

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2018

Estimated Enrollment :

668 Patients enrolled

Trial Details

Trial ID

NCT03266601

Start Date

June 1 2016

End Date

December 31 2018

Last Update

March 7 2019

Active Locations (1)

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Children's Hospital of Fudan University

Shanghai, China, 201102