Status:
COMPLETED
Safety and Efficacy of ADC189 in Children 2-11 Years Old With Influenza
Lead Sponsor:
Jiaxing AnDiCon Biotech Co.,Ltd
Conditions:
Influenza Type A
Influenza Type B
Eligibility:
All Genders
2-11 years
Phase:
PHASE3
Brief Summary
Currently, there is only one treatment which only need one single oral dose for influenza in children five years above (Baloxavir marboxil) in China. This study will test a medicine for influenza in c...
Eligibility Criteria
Inclusion
- Key
- 1\. Patients aged 2 to 11 years at screening, both sex;
- 2\. Patients were diagnosed with Influenza A Vairus Infection/Influenza B Virus Infection.
- 3\. Parents willing and able to comply with study requirements, under the judgment of investigators .
- 4\. Onset of symptoms no more than 48 hours before presentation for screening.
- Key
Exclusion
- 1\. Patients with severe influenza.
- 2\. Pregnant or breast-feeding females
- 3\. Patients with acute respiratory infection, tympanitis, sinusitis, or acute asthma attack within 2 weeks before screening.
- 4\. Presence of a chronic disease or illness that may indicate increased risk for influenza-related complications.
- 5\. Other antiviral therapy is required during screening.
Key Trial Info
Start Date :
August 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2025
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT06507813
Start Date
August 19 2024
End Date
April 15 2025
Last Update
September 23 2025
Active Locations (1)
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1
Beijing Children's Hospital,Capital Medical University
Beijing, Beijing Municipality, China