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NCT03604705 · ClinicalTrials.gov registry record · Phase 2
An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia
A Phase 2 study, sponsored by Basilea Pharmaceutica.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT03604705: Completed Phase 2 study, sponsored by Basilea Pharmaceutica.
NCT03604705 is a Phase 2 study that has completed, run by Basilea Pharmaceutica. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03604705, a Phase 2 study, has completed, sponsored by Basilea Pharmaceutica.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
This is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy and safety of APX001 for the first-line treatment for candidemia including suspected or confirmed antifungal-resistant candidemia in non-neutropenic patients 18 yeas of age and older. Suspicion of antifungal-resistant candidemia is sufficient (documented resistance is not required for enrollment). The Study Drug Treatment Period of APX001 will be a maximum of 14 days. After completion of 14 days study drug therapy, if further antifungal treatment is indicated to complete treatment of candidemia in accordance with standard practice guidelines, fluconazole (unless susceptibility results warrant alternative antifungal therapy) may commence for up to a further 7 days. There will be a Follow up Period of 4 weeks (+4 days) after EOT. The total duration of participation in the study is up to approximately 7.5 weeks. This study will be conducted at approximately 20 sites in the United States and globally.
Primary Outcome
Treatment Success is defined as meeting all of the following criteria: Two consecutive blood cultures negative for Candida spp. Alive at EOST No concomitant use of any other systemic antifungal therapies through end of study treatment
Interventions
- DRUG APX001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-10-03 |
| Est. Completion | 2020-07-02 |
| Phase | Phase 2 |
What the finished NCT03604705 record still lists
NCT03604705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which APX001 is the first listed.
NCT03604705 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03604705 about?
NCT03604705 is a clinical study titled "An Efficacy and Safety Study of APX001 in Non-Neutropenic Patients With Candidemia". This is a multicenter, open-label, non-comparative, single-arm study to evaluate the efficacy and safety of APX001 for the first-line treatment for candidemia including suspected or confirmed antifungal-resistant candidemia in non-neutropenic patients 18 yeas of age and older. Suspicion of antifung...
What is the current status of trial NCT03604705?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2018-10-03. Estimated completion is 2020-07-02.
What interventions are being tested in trial NCT03604705?
The interventions under investigation include: APX001 (DRUG).
Who is sponsoring clinical trial NCT03604705?
This trial is sponsored by Basilea Pharmaceutica, which has 21 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03604705's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 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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