A Phase 4 interventional study of Recombinant Human Interferon α-2b Spray and Ribavirin in Herpangina, sponsored by Children's Hospital of Fudan University. Completed at 1 site in China. Open to participants aged 1 Year to 7 Years. Per ClinicalTrials.gov, last updated 2019-03-07.
Sponsored by Children's Hospital of Fudan University · Phase 4, Interventional, and Treatment
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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.
Children's Hospital of Fudan University is the lead sponsor of 268 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subjects should meet all of the following:
Exclusion Criteria:
Subjects should be excluded if meet any of the following:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Recombinant Human Interferon α-2b Spray
Drug: Ribavirin
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).
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 ).
The defervesce rate during treatment by 72 hours
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.
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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From starting of treatment to the 96th hour.
The total effective rate
Total effective rate = efficiency rate + effective rate.
Time frame: From starting of treatment to the 96th hour.
Total hospital stay
Time frame: From starting of treatment to the 96th hour.
Appetite improvement
Time frame: 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.
Time frame: 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
Time frame: Check the oral herpes or ulcers subsided every 24 hours from starting of treatment to the 72th hour.
Ran from Jun 2016 to primary completion in Nov 2018, 29 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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Herpangina
Children's Hospital of Fudan University →