NL-OMON55351
Completed
Phase 3
Open-Label Study to Evaluate the Efficacy and Safety of SCY-078 in Patients with Fungal Diseases that are Refractory to or Intolerant of Standard Antifungal Treatment (FURI) - FURI
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- SCYNEXIS
- Enrollment
- 2
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subject is a male or female adult \*18 years of age on the day the study
- •informed consent form (ICF) is signed.
- •2\. Subject has a documented eligible fungal disease that has been refractory
- •to, has relapsed after, or the subject has intolerance to or demonstrated
- •toxicities resulting from an approved SOC antifungal treatment (as defined in
- •Table 5\). The subject is also eligible if, in the judgement of the
- •Investigator, long\-term IV antifungal therapy is not feasible or desirable due
- •to clinical or logistical circumstances or if other antifungal alternatives are
- •not appropriate.
- •Subject is able to tolerate medication orally or through a nasogastric (NG)
Exclusion Criteria
- •1\. Subject has an invasive fungal disease with central nervous system
- •involvement unless the subject is planned to receive combination therapy with
- •ibrexafungerp and other antifungal.
- •2\. Subject has an inappropriately controlled fungal disease source (e.g.,
- •persistent catheters, devices, identified undrained abscess) that is likely to
- •be the source of the fungal disease.
- •3\. Subject is hemodynamically unstable and/or requiring vasopressor medication
- •for blood pressure support.
- •4\. Subject has abnormal liver test parameters: AST or ALT \>10 x ULN and/or
- •total bilirubin \>5 x ULN.
Outcomes
Primary Outcomes
Not specified
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