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

Primary Purpose

Herpangina

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Recombinant Human Interferon α-2b Spray
Ribavirin
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpangina focused on measuring Aged 1-7 years old, within 72 hours of onset patients with herpangina

Eligibility Criteria

1 Year - 7 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital of Fudan University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Recombinant Human Interferon α-2b Spray

Ribavirin

Arm Description

Outcomes

Primary Outcome Measures

The defervesce rate during treatment by 72 hours
Body temperature returned to normal,and remain at least 24 hours.

Secondary Outcome Measures

Abnormal blood routine
White blood cell count, absolute neutrophil count, absolute lymphocyte count, platelet count, hemoglobin, the five indicators if one is abnormal, abnormal blood routine is defined as "1", if five indicators all are normal, abnormal blood routine is defined as "0".
The significant efficiency rate
Within 48 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers significantly improved and no new appeared, appetite significantly improved.
The effective rate
Within 72 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers improved and no new appeared, appetite improved.
The ineffective rate
After medication 72 hours still fever, oropharyngeal herpes and ulcer without reducing or even increase, eating difficulty.
The total effective rate
Total effective rate = efficiency rate + effective rate.
Total hospital stay
Appetite improvement
Myocardial enzymes and electrocardiogram
Before admission myocardial enzymes and electrocardiogram were checked, then rechecked after 72 hours treatment if abnormal.
The condition of herpes and ulcers subside
Clinical examination to check herpes subsided, ulcer wounds smaller, with or

Full Information

First Posted
August 10, 2017
Last Updated
March 6, 2019
Sponsor
Children's Hospital of Fudan University
Collaborators
Tianjin Sinobioway Biomedicine Co.Ltd., Hunan Children's Hospital, Children's Hospital of Chongqing Medical University, Yuying Children's Hospital of Wenzhou Medical University, Qilu Children's Hospital of Shandong University, Children's Hospital of Kaifeng City, Shenzhen Children's Hospital, Zunyi Medical College, Changhai Hospital, Anhui Provincial Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03266601
Brief Title
Effect of Recombinant Human Interferon α-2b Spray on Herpangina
Official Title
Effect and Safety of Recombinant Human Interferon α-2b Spray on Herpangina in Pediatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (Actual)
Primary Completion Date
November 30, 2018 (Actual)
Study Completion Date
December 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital of Fudan University
Collaborators
Tianjin Sinobioway Biomedicine Co.Ltd., Hunan Children's Hospital, Children's Hospital of Chongqing Medical University, Yuying Children's Hospital of Wenzhou Medical University, Qilu Children's Hospital of Shandong University, Children's Hospital of Kaifeng City, Shenzhen Children's Hospital, Zunyi Medical College, Changhai Hospital, Anhui Provincial Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpangina
Keywords
Aged 1-7 years old, within 72 hours of onset patients with herpangina

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
668 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recombinant Human Interferon α-2b Spray
Arm Type
Experimental
Arm Title
Ribavirin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Recombinant Human Interferon α-2b Spray
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Intervention Description
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 ).
Primary Outcome Measure Information:
Title
The defervesce rate during treatment by 72 hours
Description
Body temperature returned to normal,and remain at least 24 hours.
Time Frame
Measure the body temperature every 4 hours from starting of treatment to the 96th hour.
Secondary Outcome Measure Information:
Title
Abnormal blood routine
Description
White blood cell count, absolute neutrophil count, absolute lymphocyte count, platelet count, hemoglobin, the five indicators if one is abnormal, abnormal blood routine is defined as "1", if five indicators all are normal, abnormal blood routine is defined as "0".
Time Frame
Before admission and 72th hours after treatment.
Title
The significant efficiency rate
Description
Within 48 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers significantly improved and no new appeared, appetite significantly improved.
Time Frame
From starting of treatment to the 48th hour.
Title
The effective rate
Description
Within 72 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers improved and no new appeared, appetite improved.
Time Frame
From starting of treatment to the 72th hour.
Title
The ineffective rate
Description
After medication 72 hours still fever, oropharyngeal herpes and ulcer without reducing or even increase, eating difficulty.
Time Frame
From starting of treatment to the 96th hour.
Title
The total effective rate
Description
Total effective rate = efficiency rate + effective rate.
Time Frame
From starting of treatment to the 96th hour.
Title
Total hospital stay
Time Frame
From starting of treatment to the 96th hour.
Title
Appetite improvement
Time Frame
From starting of treatment to the 96th hour.
Title
Myocardial enzymes and electrocardiogram
Description
Before admission myocardial enzymes and electrocardiogram were checked, then rechecked after 72 hours treatment if abnormal.
Time Frame
Before admission and 72th hours after treatment.
Title
The condition of herpes and ulcers subside
Description
Clinical examination to check herpes subsided, ulcer wounds smaller, with or
Time Frame
Check the oral herpes or ulcers subsided every 24 hours from starting of treatment to the 72th hour.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Children's Hospital of Fudan University
City
Shanghai
ZIP/Postal Code
201102
Country
China

12. IPD Sharing Statement

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

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