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NCT00634049 · ClinicalTrials.gov registry record · Phase 3
Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi
A Phase 3 study, sponsored by Astellas Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 149
- Enrollment target
NCT00634049: Completed Phase 3 study, sponsored by Astellas Pharma.
NCT00634049 is a Phase 3 study that has completed, run by Astellas Pharma. The registered enrollment target is 149 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00634049, a Phase 3 study, has completed, sponsored by Astellas Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 149 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi.
Primary Outcome
The DRC assessed overall response based on individual clinical, mycological and radiological response assessments. Overall response outcomes were described as Success (complete or partial). Complete success was defined as a resolution of all clinical symptoms and physical findings associated with IFD. Partial success was defined as a resolution of at least some clinical symptoms and physical findings associated with IFD End of treatment (EOT) is the last day of study drug administration, with an
Interventions
- DRUG isavuconazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 149 participants |
| Start Date | 2008-04-22 |
| Est. Completion | 2016-05-05 |
| Phase | Phase 3 |
What the finished NCT00634049 record still lists
NCT00634049 is an interventional study that assigns participants to a tested intervention. The registered 149 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which isavuconazole is the first listed.
NCT00634049 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00634049 about?
NCT00634049 is a clinical study titled "Isavuconazole in the Treatment of Renally Impaired Aspergillosis and Rare Fungi". The purpose of this study is to investigate the efficacy and safety of isavuconazole in the treatment of renally impaired participants with invasive fungal infections caused by Aspergillus and participants with invasive fungal disease caused by rare fungi.
What is the current status of trial NCT00634049?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 149 participants. The study started on 2008-04-22. Estimated completion is 2016-05-05.
What interventions are being tested in trial NCT00634049?
The interventions under investigation include: isavuconazole (DRUG).
Who is sponsoring clinical trial NCT00634049?
This trial is sponsored by Astellas Pharma, which has 165 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00634049's enrollment target sits among peer trials
149 1546th of 2000 higher than 454 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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