Trials / Completed
CompletedNCT04218851
Posaconazole (MK-5592) Intravenous and Oral in Children With Invasive Aspergillosis (IA) (MK-5592-104)
A Phase 2, Open-Label, Non-Comparative Clinical Trial to Study the Safety and Efficacy of Posaconazole (POS, MK-5592) in Pediatric Participants Aged 2 to Less Than 18 Years With Invasive Aspergillosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Merck Sharp & Dohme LLC · Industry
- Sex
- All
- Age
- 2 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the safety, efficacy, and pharmacokinetics of posaconazole (POS) intravenous (IV) and oral formulations in pediatric participants 2 to \<18 years of age with invasive aspergillosis (IA).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Posaconazole IV | Posaconazole (POS) 6 mg/kg body weight by IV infusion |
| DRUG | Posaconazole PFS | Dosing based on weight-band taken orally |
| DRUG | Posaconazole tablet | POS tablet 300 mg taken orally |
Timeline
- Start date
- 2020-07-02
- Primary completion
- 2023-12-18
- Completion
- 2023-12-18
- First posted
- 2020-01-06
- Last updated
- 2025-01-14
- Results posted
- 2025-01-14
Locations
29 sites across 10 countries: United States, Belgium, Greece, Hungary, Israel, Italy, Mexico, Peru, Russia, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04218851. Inclusion in this directory is not an endorsement.