Open-Label Study to Evaluate Efficacy and Safety of SCY-078 in Patients With Refractory or Intolerant Fungal Diseases (FURI)
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|ClinicalTrials.gov Identifier: NCT03059992|
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Invasive Candidiases Mucocutaneous Candidiasis||Drug: SCY-078||Phase 3|
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of SCY-078 in patients ≥ 18 years of age with a documented invasive and/or severe fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment. Patients will be treated with SCY-078 for up to 90 days.
Subjects must have a proven or probable fungal disease and meet all study criteria to be considered for enrollment. Eligible subjects must also have documented evidence of failure of, intolerance to, or toxicity related to a currently approved SoC antifungal treatment.
Subjects will also be considered for enrollment if they have an eligible fungal disease and, in the judgement of the investigator, the subject cannot receive approved oral antifungal options (e.g. susceptibility of the organism or risk for drug-drug interactions) and a continued IV antifungal therapy is not desirable or feasible due to clinical or logistical circumstances.
Following a screening visit, there will be up to 11 treatment visits, a follow-up visit and 2 follow-up contacts.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||open label, non-comparator, single arm|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||April 1, 2017|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||December 2019|
Experimental Study Drug
- Assessment of Global Response [ Time Frame: Up to 90 days of study treatment ]The proportion of subjects with a complete or partial Global Response (GR) at the End of Treatment Visit.
- Assessment of Recurrence of Baseline Fungal Infection [ Time Frame: up to 42 days after end of study treatment ]The proportion of subjects with a recurrence of the baseline fungal infectoin
- Assessment of survival [ Time Frame: Day 42, Day 84 ]Proportion of surviving subjects
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03059992
|Contact: David Angulo, MDfirstname.lastname@example.org|
|Contact: Kristin Bennettemail@example.com|
Show 24 Study Locations
|Study Director:||David Angulo, MD||Sponsor GmbH|