An interventional study of Peginterferon α-2b injection and Recombinant Human Interferon α2b in Bronchiolitis, sponsored by Children's Hospital of Soochow University. Recruiting at 3 sites in China. Open to participants aged 6 Months to 2 Years. Per ClinicalTrials.gov, last updated 2025-02-14.
Sponsored by Children's Hospital of Soochow University · Not applicable, Interventional, and Treatment
This is a multicenter, randomized, positive-controlled, non-inferiority clinical study, planning to enroll 90 children with bronchiolitis caused by respiratory syncytial virus infection, to evaluate the safety and efficacy of inhaled Peginterferon α-2b injection compared to recombinant human interferon α2b in the treatment of pediatric respiratory syncytial virus bronchiolitis.
289 studies on the registry are indexed under Bronchiolitis; 51 are open to participants now.
This study's planned enrollment of 90 is close to the median of 100 across 195 interventional studies indexed under Bronchiolitis.
Browse Bronchiolitis studies →Children's Hospital of Soochow University is the lead sponsor of 6 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
(10) Other conditions deemed unsuitable for inclusion by the investigator.
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.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
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.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The experimental group participants inhaled Peginterferon on the basis of receiving symptomatic supportive treatment.
Drug: Peginterferon α-2b injection
The control group participants received symptomatic supportive treatment and aerosolized inhalation therapy with recombinant human interferon α-2b.
Drug: Recombinant Human Interferon α2b
Peginterferon α-2b injection, 90 mcg, on the basis of conventional treatments such as asthma control, oxygen inhalation, and fluid replacement, nebulized inhalation using air compression or oxygen-driven methods is administered on days 1, 3, and 5, once a day.
Recombinant Human Interferon alpha 2b, at a dose of 100,000 IU/kg, based on the conventional treatments such as asthma control, oxygen inhalation, and fluid replacement, will be administered via nebulized inhalation using air compression or oxygen-driven methods from day 1 to day 5, twice daily.
The rate of change in Wang's bronchiolitis score from baseline.
Time frame: Day 6.
Wang's bronchiolitis score change from baseline.
Time frame: Day1-7.
The proportion of Wang's bronchiolitis score being 0 points.
Time frame: Day6.
Length of hospital stay.
Time frame: through study completion, an average of 18 months
Duration of oxygen therapy support.
Time frame: through study completion, an average of 18 months
Change in viral load from baseline.
Time frame: through study completion, an average of 18 months
Adverse Event(AE).
Time frame: through study completion, an average of 18 months
Body temperature.
Time frame: through study completion, an average of 18 months
Number of Participants with Abnormal Laboratory Parameters Findings.
Time frame: through study completion, an average of 18 months
The number of research subjects who withdrew early.
Time frame: through study completion, an average of 18 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Mar 2025; primary completion for Jun 2026, 15 months later.
Of 54 non-industry interventional studies with no phase under Bronchiolitis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 35. This study's planned 15 months is below that.
Counting every sponsor, half of 57 studies reached it within 22 months; a quarter within 11 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Peginterferon alfa-2b
Children's Hospital of Soochow University