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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03672292
Registration number
NCT03672292
Ethics application status
Date submitted
11/09/2018
Date registered
14/09/2018
Date last updated
9/08/2024
Titles & IDs
Public title
Evaluate Safety and Efficacy of the Coadministration of Ibrexafungerp With Voriconazole in Patients With Invasive Pulmonary Aspergillosis
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Scientific title
A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Coadministration of SCY-078 With Voriconazole in Patients With Invasive Pulmonary Aspergillosis
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Secondary ID [1]
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2018-002565-18
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Secondary ID [2]
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SCY-078-206
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Universal Trial Number (UTN)
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Trial acronym
SCYNERGIA
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Invasive Pulmonary Aspergillosis
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Condition category
Condition code
Infection
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Other infectious diseases
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Infection
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Studies of infection and infectious agents
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SCY-078
Treatment: Drugs - Voriconazole
Other interventions - Oral Placebo Tablets
Experimental: SCY-078 plus Voriconazole - Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards).
PLUS Oral SCY-078 tablets (loading dose of 500 mg BID on Days 1 and 2 followed by maintenance dose of 500 mg QD from Day 3 onwards). Treatment duration = minimum 6 weeks/Max 13 weeks
Placebo comparator: Voriconazole mono-therapy - Either IV voriconazole (loading dose of 6 mg/kg BID on Day 1 followed by maintenance dose of 4 mg/kg BID from Day 2 onwards) OR oral voriconazole (loading dose of 400 mg BID on Day 1 followed by maintenance dose of 200 mg BID from Day 2 onwards).
PLUS Oral Placebo Tablets matching SCY-078 tablets (loading dose of 2 tablets given BID on Days 1 and 2 followed by maintenance dose of 2 tablets given QD from Day 3 onwards).
Treatment duration = minimum 6 weeks/Max 13 weeks
Treatment: Drugs: SCY-078
Oral tablets of SCY-078
Treatment: Drugs: Voriconazole
Voriconazole IV vials or oral tablets
Other interventions: Oral Placebo Tablets
Oral Placebo Tablets matching SCY-078
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs), Drug-related Adverse Events (AEs), Discontinuations Due to AEs and Deaths
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Assessment method [1]
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Number of participants with treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), discontinuations due to AEs and deaths.
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Timepoint [1]
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Up to a maximum of 19 weeks
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Secondary outcome [1]
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Percentage of Participants With Complete Response or Partial Response as Determined by the Data Review Committee (DRC)
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Assessment method [1]
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Number and percentage of participants with Complete Response or Partial Response as determined by the Data Review Committee (DRC). Complete Response: Survival and resolution of all attributable symptoms and signs of disease; plus, successful radiological outcome; plus, mycological eradication. Partial Response: Survival and partial resolution of attributable symptoms and signs of disease; plus, improvement (at least 25%) of radiological lesions; plus, mycological eradication.
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Timepoint [1]
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At end of treatment (up to 13 weeks), day 42 and day 84
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Secondary outcome [2]
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Percentage of Participants Who Died (Any Cause)
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Assessment method [2]
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Number and Percentage of participants who died (any cause)
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Timepoint [2]
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At Day 42 and Day 84
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Secondary outcome [3]
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Change in Serum Galactomannan Index (GMI)
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Assessment method [3]
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Absolute change in serum GMI from from baseline to each time point (Weeks 1, 2, 4 and 6). Negative values indicate a reduction of GMI (i.e., improvement).
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Timepoint [3]
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Weeks 1, 2, 4 and 6
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Secondary outcome [4]
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Percent of Participants With Changes in GMI
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Assessment method [4]
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Percentage of participants with the following changes in GMI values from Baseline: * Fifty percent reduction or greater at Weeks 1, 2, 4 and 6 * Twenty-five percent reduction or greater at Weeks 1, 2, 4 and 6 * Any percent reduction at Weeks 1, 2, 4 and 6 * Reduction equal to or greater than 0.25 at Weeks 1, 2, 4 and 6 * Reduction to \< 0.5 at Weeks 1, 2, 4 and 6
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Timepoint [4]
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Weeks 1, 2, 4 and 6 from Baseline
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Secondary outcome [5]
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Time to Achieve Serum GMI Change From Baseline
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Assessment method [5]
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Time (days) to achieve the following changes in serum GMI from Baseline: * Fifty percent reduction * Twenty-five percent reduction * Any percent reduction * Reduction equal to or greater than 0.25
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Timepoint [5]
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Up to a maximum of 19 weeks
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Secondary outcome [6]
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Percentage of Participants With a Clinical, Mycological and Radiological Response by DRC
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Assessment method [6]
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Percentage of participants with: * Clinical Response at EoT, Day 42 and Day 84, as determined by the DRC * Mycological Response at EoT, Day 42 and Day 84, as determined by the DRC * Radiological Response at EoT, Day 42 and Day 84, as determined by the DRC
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Timepoint [6]
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End of Treatment (EoT), Day 42 and Day 84
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Secondary outcome [7]
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Percentage of Participants With a Clinical, Mycological and Radiological Response.
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Assessment method [7]
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Percentage of participants with: * Clinical Response at EoT, Day 42 and Day 84, as determined by the Principal Investigator * Mycological Response at EoT, Day 42 and Day 84, as determined by the Principal Investigator * Radiological Response at EoT, Day 42 and Day 84, as determined by the Principal Investigator
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Timepoint [7]
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End of Treatment (EoT), Day 42 and Day 84
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Secondary outcome [8]
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SCY-078 and Voriconazole Plasma Concentrations
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Assessment method [8]
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Voriconazole and SCY-078 plasma concentrations (ng/mL)
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Timepoint [8]
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Treatment Days 7 and 14 (2-4 hrs post dose)
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Eligibility
Key inclusion criteria
1. 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 probable or proven IPA based on the protocol-specified criteria (Section 22.3) that requires antifungal treatment. Note: Subjects with possible IPA may enter the screening phase of the study but will only be randomized after meeting criteria for probable or proven IPA.
3. Subject has a result of a serum GMI from a sample obtained within the 96 hours preceding enrollment into the study (Baseline/Treatment Day 1).
4. Subject has a diagnosis of a hematological malignancy or a myelodysplastic syndrome or aplastic anemia or has undergone hematopoietic cell transplantation OR
5. Subject who either recently resolved or ongoing neutropenia (neutropenia defined as absolute neutrophil count < 0.5 x 10?/L [< 500/mm³] for > 10 days), temporally related to the onset of fungal disease OR
6. Subject who received treatment with other recognized T-cell immunosuppressants (such as cyclosporine, tacrolimus, monoclonal antibodies or nucleoside analogs) during the past 90 days including solid organ transplant patients OR
7. Subject with inherited severe immunodeficiency (e.g. chronic granulomatous disease, severe combined immunodeficiency)
8. Subject has not received more than 4 days (96 hours) of prior mold-active antifungal therapy for the treatment of the IPA episode in the 7 days preceding enrollment into the study (Baseline/Treatment Day 1). However, subjects who have received more than 4 days but less than 7 days of prior mold-active antifungal therapy for the treatment of the IPA episode in the 7 days preceding enrollment into the study may be enrolled but will require approval from the study medical monitor, who will evaluate each subject on a case-by-case basis.
9. Subject has an IPA episode that, in the investigator´s judgement, requires antifungal therapy and may be adequately treated with voriconazole (i.e., the IPA is not a breakthrough infection while receiving a mold-active azole antifungal [voriconazole, posaconazole, isavuconazole or itraconazole] that requires therapy with a non-azole antifungal agent).
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Subject has a fungal disease with central nervous system involvement suspected at Screening.
2. Subject is receiving, has received or anticipates to be receiving concomitant medications that are listed in the prohibited medication list (Appendix A in full protocol) within the specified washout periods.
3. Subject has a Karnofsky score <20.
4. Subject is expected to die from a non-infectious cause within 30 days from the day the study ICF is signed.
5. Subject is under mechanical ventilation.
6. Subject has abnormal liver test parameters: AST or ALT >5 x ULN and/or total bilirubin >2.5 x ULN.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
22/01/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/03/2023
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Sample size
Target
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Accrual to date
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Final
22
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Massachusetts
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Country [2]
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United States of America
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State/province [2]
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Michigan
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Country [3]
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United States of America
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State/province [3]
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North Carolina
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Country [4]
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Belgium
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State/province [4]
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Brugge
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Country [5]
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Belgium
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State/province [5]
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Leuven
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Country [6]
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Canada
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State/province [6]
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Ontario
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Country [7]
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Germany
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State/province [7]
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Köln
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Country [8]
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South Africa
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State/province [8]
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Gauteng
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Scynexis, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Study to evaluate the safety and efficacy of coadminstration of SCY-078 with a mold-active azole (voriconazole) compared to voriconazole in patients with invasive pulmonary aspergillosis.
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Trial website
https://clinicaltrials.gov/study/NCT03672292
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
Name
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David Angulo, MD
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Address
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Scynexis, Inc.
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/92/NCT03672292/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/92/NCT03672292/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT03672292
Download to PDF