drugset / Trial / NCT03740997
Study to Determine Safety and Dosage of OPTISON in Pediatric Participants
Non-randomizedSingle-groupOpen-labelDiagnostic
Summary
Study to determine the safety and appropriate dosage of OPTISON in pediatric participants since OPTISON has been tested in adult participants only during the clinical development
Timeline
- Start
- 2020-12-01
- Primary completion
- 2023-03-30
- Completion
- 2023-03-30
Outcome
Met primary endpoint
registry analysis (other test); Body Weight Group <=40 kg: OPTISON; p = 0.0008; Mean Difference (Net) 16.2 (95% CI 10.44 to 21.89); Paired t-test NCT03740997 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Optison | Diagnostic / imaging agent | 0.1 ml | Intravenous |
| Subject | Optison | Diagnostic / imaging agent | 0.2 ml | Intravenous |
| Subject | Optison | Diagnostic / imaging agent | 0.3 ml | Intravenous |
| Subject | Optison | Diagnostic / imaging agent | 0.4 ml | Intravenous |