Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 2 study that has completed, run by Basilea Pharmaceutica. The registered enrollment target is 21 participants.
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.
Interventions
- DRUG APX001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-10-03 |
| Est. Completion | 2020-07-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03604705
The ClinicalTrials.gov registry entry for NCT03604705 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Basilea Pharmaceutica, which has 21 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which APX001 is the first listed.
NCT03604705 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.