A Phase 2 interventional study of Investigational Agent: VL-2397 and Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B in Invasive Aspergillosis and Invasive Pulmonary Aspergillosis, sponsored by Vical. Terminated at 28 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Vical · Phase 2, Interventional, and Treatment
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The purpose of the trial is to evaluate the safety and efficacy of a new antifungal with a novel mechanism of action in immunocompromised adults with invasive aspergillosis.
To compare the safety and efficacy of VL-2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant (allo-HCT).
43 studies on the registry are indexed under Invasive Pulmonary Aspergillosis; 9 are open to participants now.
This study's enrollment of 4 is below the median of 63 across 12 interventional studies indexed under Invasive Pulmonary Aspergillosis.
Browse Invasive Pulmonary Aspergillosis studies →Vical is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Investigational agent VL-2397 600 mg IV infusion administered every day for 28 days (4 weeks) followed by 2 weeks of standard treatment
Drug: Investigational Agent: VL-2397 · Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
Investigator selected standard treatments of voriconazole, isavuconazole, or liposomal amphotericin B administered every day for 42 days (6 weeks) per product package insert
Drug: Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B
VL-2397
Voriconazole, Isavuconazole, or Liposomal amphotericin B
All-cause mortality (ACM)
Time frame: 4 weeks
ACM
Time frame: 6 weeks
Number of participants with adverse events
Number of participants with adverse events
Time frame: 6 weeks
Plan to share: No
No publications or documents are linked to this record.
Ran from Feb 2018 to primary completion in Jan 2019, 10 months.
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This study is terminated, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Invasive Pulmonary Aspergillosis →
Vical