NCT03266601

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 herpangina.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
668

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 10, 2017

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 30, 2017

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2018

Completed
Last Updated

March 7, 2019

Status Verified

March 1, 2019

Enrollment Period

2.5 years

First QC Date

August 10, 2017

Last Update Submit

March 6, 2019

Conditions

Herpangina

Keywords

Aged 1-7 years old, within 72 hours of onset patients with herpangina

Outcome Measures

Primary Outcomes (1)

  • The defervesce rate during treatment by 72 hours

    Body temperature returned to normal,and remain at least 24 hours.

    Measure the body temperature every 4 hours from starting of treatment to the 96th hour.

Secondary Outcomes (9)

  • Abnormal blood routine

    Before admission and 72th hours after treatment.

  • The significant efficiency rate

    From starting of treatment to the 48th hour.

  • The effective rate

    From starting of treatment to the 72th hour.

  • The ineffective rate

    From starting of treatment to the 96th hour.

  • The total effective rate

    From starting of treatment to the 96th hour.

  • +4 more secondary outcomes

Study Arms (2)

Recombinant Human Interferon α-2b Spray

EXPERIMENTAL
Drug: Recombinant Human Interferon α-2b Spray

Ribavirin

ACTIVE COMPARATOR
Drug: Ribavirin

Interventions

Recombinant Human Interferon α-2b SprayDRUG

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).

Recombinant Human Interferon α-2b Spray
RibavirinDRUG

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 ).

Ribavirin

Eligibility Criteria

Age1 Year - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, 201102, China

Location

MeSH Terms

Conditions

Herpangina

Interventions

Ribavirin

Condition Hierarchy (Ancestors)

Coxsackievirus InfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesInfectionsEchovirus Infections

Intervention Hierarchy (Ancestors)

RibonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director

Study Record Dates

First Submitted

August 10, 2017

First Posted

August 30, 2017

Study Start

June 1, 2016

Primary Completion

November 30, 2018

Study Completion

December 31, 2018

Last Updated

March 7, 2019

Record last verified: 2019-03

Locations

CN(1)