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Olorofim Aspergillus Infection Study

Study acronym: OASIS
StatusCompleted
PhasePhase 3
SponsorF2G Ltd
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: F2G Biotech GmbH to F2G Ltd Show 7 more changesShow less
    • Trial completed
    • Trial sites expanded: 140 → 143 locations
    • Study completion date changed from estimate of Nov 1, 2026 to Mar 19, 2026
    • Start date: Mar 31, 2022 to Apr 29, 2022
    • Eligibility criteria expanded, about 14 words
    • Secondary endpoints: details revised at 4 of 9 entries
    • Publications: details revised at 1 of 1 entry
  2. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Sep 14, 2025 to Nov 18, 2025
    • Site details revised at 140 of 140 sites
    v10
  3. Study sites: 136 to 140v9
  4. Study sites: 101 to 136v8
  5. Primary completion date: Sep 14, 2024 to Sep 14, 2025
    • Study completion date: Nov 1, 2025 to Nov 1, 2026
    v7
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  1. Study sites: 49 to 101v6 Show 4 more changesShow less
    • Study completion date: Mar 4, 2025 to Nov 1, 2025
    • Eligibility criteria expanded, about 62 words
    • Secondary endpoints: 3 to 9
    • Collaborators: 1 to 2
  2. Site details revised at 1 of 49 sitesv5
  3. Study sites: 45 to 49v4
  4. Study sites: 1 to 45v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 30, 2021 to Mar 31, 2022
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
F2G Ltd
2 trials monitored
See 1 trial at risk
The purpose of this study is to compare treatment with olorofim versus treatment with AmBisome® followed by standard of care (SOC) in patients with IFD caused by proven IA or probable lower respiratory tract disease Aspergillus species (invasive aspergillosis, IA).
Trial Details
NCT Number NCT05101187
Lead Sponsor F2G Ltd
Collaborators: IQVIA Pty Ltd, Shionogi
Conditions
(from sponsor)		 Invasive Aspergillosis
Related terms Invasive Fungal Infections
Enrollment 225 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov