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A phase 3 study of Niyad™ (nafamostat)

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Trial Profile

A phase 3 study of Niyad™ (nafamostat)

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 20 Jan 2025

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At a glance

  • Drugs Nafamostat (Primary)
  • Indications Disseminated intravascular coagulation
  • Focus Registrational; Therapeutic Use
  • Acronyms NEPHRO CRRT

    • Most Recent Events

    • 14 Jan 2025 According to a Talphera media release, In addition to new clinical sites, continuous improvement efforts in study execution, company is also looking for completion of the NEPHRO CRRT study by the end of the year.
    • 14 Jan 2025 According to a Talphera media release, FDA agreed to two additional protocol changes expected to accelerate enrollment in the NEPHRO CRRT study. Company to enroll patients already on continuous renal replacement therapy (CRRT) beyond 48 hours as well as heparin-tolerant patients at certain institutions. These changes are being made through a five-day protocol amendment notice to the FDA with no additional FDA review required.
    • 14 Jan 2025 According to a Talphera media release, following a meeting with the U.S. Food and Drug Administration (FDA), the agency has agreed to review a Prior Approval Supplement (PAS) requesting a reduction in the number of patients in the NEPHRO CRRT clinical study. A PAS is reviewed by the FDA within 30 days, and its approval by the agency is required before formally amending the study protocol.

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