Trial | NCT03266601  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    668
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.
Study Started
Jun 01
2016
Primary Completion
Nov 30
2018
Study Completion
Dec 31
2018
Last Update
Mar 07
2019

Drug Recombinant Human Interferon α-2b Spray

Recombinant human interferon α-2b spray (trade name Jeferon, specifications: 1 million U/support, 10mL/support or 2 million U/support, 20mL/support, 2-8 ℃ dark storage and transportation), 1 million U/day, used for 3 days, observed to the 4th day (until the 96th hour).

Drug Ribavirin

Ribavirin Spray, spray once every 4-5 hours, 1-2 times a spray, used for 3 days, observed to the 4th day(until the 96th hour ).

Recombinant Human Interferon α-2b Spray Experimental

Ribavirin Active Comparator

Criteria 

Inclusion Criteria:

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 Criteria:

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.
No Results Posted