Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06363370
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2024-04-07
Brief Title:
Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections
Sponsor:
Kexing Biopharm Co Ltd
Organization:
Kexing Biopharm Co Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Phase III Clinical Study to Evaluate the Safety and Efficacy of Human Interferon α1b Inhaled Solution in the Treatment of Respiratory Syncytial Virus Lower Respiratory Tract Infection in Children
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the efficacy and safety of interferon α1b GB05 in the treatment of children under 2 years of age with respiratory syncytial virus infection
Detailed Description:
The study has been divided into two parts 60 subjects will be randomly assigned to the 4μgkg dose group or 6μgkg dose group or the blank control group to receive nebulized GB05 therapy twice daily for no more than 7 days After comprehensive evaluation of effectiveness and safety and confirmation of the optimal dose the sample size will be re-calculated to enter the second part of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None