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NCT03816176 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants
A Phase 2 study, sponsored by Astellas Pharma Global Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
NCT03816176: Completed Phase 2 study, sponsored by Astellas Pharma Global Development.
NCT03816176 is a Phase 2 study that has completed, run by Astellas Pharma Global Development. The registered enrollment target is 31 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03816176, a Phase 2 study, has completed, sponsored by Astellas Pharma Global Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
Study Summary
The purpose of this study was to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.
Primary Outcome
An AE is any untoward medical occurrence in a participant administered a study drug, which does not have to have a causal relationship with this treatment. It can be any unfavorable sign, symptom, or disease temporally associated with the use of a medicinal product. TEAE is defined as an AE observed after starting administration of the study drug through 30 days after the last dose.
Interventions
- DRUG Isavuconazonium sulfate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2019-08-22 |
| Est. Completion | 2022-12-14 |
| Phase | Phase 2 |
What the finished NCT03816176 record still lists
NCT03816176 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Isavuconazonium sulfate is the first listed.
NCT03816176 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03816176 about?
NCT03816176 is a clinical study titled "A Study to Evaluate Isavuconazonium Sulfate for the Treatment of Invasive Aspergillosis (IA) or Invasive Mucormycosis (IM) in Pediatric Participants". The purpose of this study was to evaluate the safety, tolerability, and efficacy of isavuconazonium sulfate in pediatric participants.
What is the current status of trial NCT03816176?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2019-08-22. Estimated completion is 2022-12-14.
What interventions are being tested in trial NCT03816176?
The interventions under investigation include: Isavuconazonium sulfate (DRUG).
Who is sponsoring clinical trial NCT03816176?
This trial is sponsored by Astellas Pharma Global Development, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03816176's enrollment target sits among peer trials
31 1578th of 2000 higher than 419 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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