drugset / Trial / NCT03481894
Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age
RandomizedParallel-groupOpen-labelSupportive care
Summary
Demonstrate the safety and efficacy of Kabiven compared to standard parenteral nutrition (PN) administered via central vein in pediatric patients (2 to 16 years of age) requiring PN to meet nutritional needs.
Timeline
- Start
- 2018-03
- Primary completion
- 2020-03
- Completion
- 2021-03
Outcome
Outcome not reported
Stopped: “FDA released Fresenius Kabi from this post marketing requirement on 07/16/2019.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Kabiven® | Other / unclassified | 12.5 ml | Intravenous |
| Subject | Kabiven® | Other / unclassified | 25 ml | Intravenous |