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An Open-label, Dose-Finding, Phase 1/2 Study to Evaluate the Safety and Tolerability of a Single Intravenous Dose of LY3884961 in Patients With Peripheral Manifestations of Gaucher Disease (PROCEED)

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Trial Profile

An Open-label, Dose-Finding, Phase 1/2 Study to Evaluate the Safety and Tolerability of a Single Intravenous Dose of LY3884961 in Patients With Peripheral Manifestations of Gaucher Disease (PROCEED)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 24 Mar 2025

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At a glance

  • Drugs Methylprednisolone (Primary) ; PR 001 (Primary) ; Prednisone (Primary) ; Sirolimus (Primary)
  • Indications Gaucher's disease
  • Focus Adverse reactions
  • Acronyms PROCEED
  • Sponsors Prevail Therapeutics

Most Recent Events

  • 20 Feb 2024 Planned End Date changed from 11 Sep 2030 to 2 Oct 2030.
  • 20 Feb 2024 Planned primary completion date changed from 11 Sep 2030 to 2 Oct 2030.
  • 29 Aug 2023 The protocol has been amended as above-1) Number of treatment arms has been changed from 4 to 1. 2) primary endpoint has been amended.

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