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

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 Overview

• Status: Completed
• Conditions: Herpangina
• Intervention / Treatment: Drug: Recombinant Human Interferon α-2b Spray; Drug: Ribavirin

• Study Type: Interventional
• Enrollment (Actual): 668
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 201102
    • Children's Hospital of Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Recombinant Human Interferon α-2b Spray	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).
Active Comparator: Ribavirin	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 ).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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".	Before admission and 72th hours after treatment.
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.	From starting of treatment to the 48th hour.
The effective rate	Within 72 hours treatment temperature returned to normal, oropharyngeal herpes and ulcers improved and no new appeared, appetite improved.	From starting of treatment to the 72th hour.
The ineffective rate	After medication 72 hours still fever, oropharyngeal herpes and ulcer without reducing or even increase, eating difficulty.	From starting of treatment to the 96th hour.
The total effective rate	Total effective rate = efficiency rate + effective rate.	From starting of treatment to the 96th hour.
Total hospital stay		From starting of treatment to the 96th hour.
Appetite improvement		From starting of treatment to the 96th hour.
Myocardial enzymes and electrocardiogram	Before admission myocardial enzymes and electrocardiogram were checked, then rechecked after 72 hours treatment if abnormal.	Before admission and 72th hours after treatment.
The condition of herpes and ulcers subside	Clinical examination to check herpes subsided, ulcer wounds smaller, with or	Check the oral herpes or ulcers subsided every 24 hours from starting of treatment to the 72th hour.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): November 30, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): March 7, 2019
• Last Update Submitted That Met QC Criteria: March 6, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Aged 1-7 years old, within 72 hours of onset patients with herpangina
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Enterovirus Infections; Picornaviridae Infections; Coxsackievirus Infections; Echovirus Infections; Herpangina; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Antimetabolites; Antineoplastic Agents; Interferons; Ribavirin
• Other Study ID Numbers: AFL-2015-2.0

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No