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

Herpangina Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03266601
• Other study ID #: AFL-2015-2.0
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2016
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2019
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 668
• Est. completion date: December 31, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Herpangina

Intervention

Drug:
• Recombinant Human Interferon a-2b Spray
Recombinant human interferon a-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).
• 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 ).

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai

Sponsors (11)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	The total effective rate	Total effective rate = efficiency rate + effective rate.	From starting of treatment to the 96th hour.
Secondary	Total hospital stay		From starting of treatment to the 96th hour.
Secondary	Appetite improvement		From starting of treatment to the 96th hour.
Secondary	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.
Secondary	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.