Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That … (NCT03059992) | Clinical Trial Compass
CompletedPhase 3
Study to Evaluate the Efficacy and Safety of Ibrexafungerp in Patients With Fungal Diseases That Are Refractory to or Intolerant of Standard Antifungal Treatment
United States233 participantsStarted 2017-04-01
Plain-language summary
This is a multicenter, open label, non-comparator, single arm study to evaluate the efficacy and safety of ibrexafungerp (SCY-078) in patients ≥ 18 years of age with a documented fungal disease that has been intolerant or refractory (rIFI) to Standard of Care (SoC) antifungal treatment.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Must have a documented eligible invasive and/or severe fungal disease that is refractory or intolerant to Standard-of-Care treatment
✓. Be able to tolerate medication orally or through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube
✓. Be able to understand and sign a written informed consent form (ICF), which must be obtained prior to treatment and any study-related procedures.
✓. Be able to understand and sign a consent or authorization form which shall permit the use, disclosure and transfer of the subject's personal health information. (e.g., in the U.S. HIPAA Authorization form).
✓. Be able to understand and follow all study-related procedures including study drug administration.
✓. Agree to use a medically acceptable method of contraception while receiving protocol-assigned product.
Exclusion criteria
✕. An invasive fungal disease with CNS involvement.
✕. Subject has an inappropriately controlled fungal disease source (e.g., persistent catheters that cannot be removed and are likely the source of infection).
✕. Subject is hemodynamically unstable, requiring vasopressor medication for blood pressure support.
✕. A life expectancy \< 30 days.
✕. Subject with abnormal liver test parameters: aspartate aminotransferase (AST), alanine aminotransferase (ALT) \>10 x the upper limit of normal (ULN), and/or total bilirubin \> 5 x ULN.
What they're measuring
1
Percentage of Participants Who Achieve a Global Response as Determined by the Data Review Committee (DRC) by Fungal Disease.
Timeframe: Vulvovaginal Candidiasis: Day 17. Chronic Mucocutaneous Candidiasis: EOT up to Day 84. Chronic Pulmonary Aspergillus and Allergic Bronchopulmonary Aspergillosis: EOT up to Day 90. All other diseases: EOT up to Day 180. All Days measured from Baseline.