Human Interferon α1b Inhalation Solution Against Respiratory Syncytial Virus in Children With Lower Respiratory Tract Infections
Recruiting
Phase 3
Interventional Study
Respiratory Syncytial Virus Infections
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 2 Months – 2
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 322 (estimated)
- Sponsor
- Kexing Biopharm Co., Ltd. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. 2 months ≤ age ≤ 2 years of age (including the correction age of premature babies, after the correction of the monthly age = (Current Date-birth date)-\[(37 weeks-fetal age)/4\], gender is not limited;
2. Comply with the following diagnostic criteria:
1\) RSV real -time reve…