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Phase 3 Study of Fibrinogen Concentrate (CSL511) in Subjects With Pseudomyxoma Peritonei Undergoing Cytoreductive Surgery

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date: Sep 1, 2026 to Sep 1, 2027 Completion date: Oct 30, 2026 to Oct 29, 2027 · Eligibility criteria expanded, about 12 words · Site contact updatedv5 Show 3 more changesShow less
    • Completion date: Oct 30, 2026 to Oct 29, 2027
    • Eligibility criteria expanded, about 12 words
    • Site contact updated

    See this version in full on ClinicalTrials.gov ↗

  2. Site contact updatedv4
  3. Eligibility criteria shortened, about 39 words Secondary endpoints: details revised at 4 of 22 entriesv3 Show 1 more changeShow less
    • Secondary endpoints: details revised at 4 of 22 entries

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Sep 30, 2024 to Oct 1, 2024v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Sep 30, 2024 to Oct 1, 2024
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
CSL Behring
30 trials monitored
See 2 trials at risk
This study is a phase 3, prospective, single center, randomized, open label, controlled, parallel arm, interventional study to investigate the efficacy and safety of CSL511, in participants undergoing cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC) for pseudomyxoma peritonei (PMP) with predicted intraoperative blood loss of greater than or equal to (\>=) 2 liter (L). Eligible participants will be randomized in a 1:1 ratio to 1 of 2 treatment arms, to receive CSL511 or cryoprecipitate.
Trial Details
NCT Number NCT06617897
Lead Sponsor CSL Behring
Conditions Acquired Fibrinogen Deficiency
Enrollment 90 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov