Trial intelligence / Profile preview

Safety of Weekly Subcutaneous Pegzilarginase in Arginase 1 Deficiency

NCT05676853Phase 3

Key facts

Status
Terminated
Start
Apr 2023
Primary completion
Apr 2023
Countries
1
Modality
PEGylated Peptides, Replacement Enzymes
Conditions
arginase 1 deficiency (ARG1-D)
01

Overview

Phase 3, open-label, single-arm trial of pegzilarginase in arginase 1 deficiency (ARG1-D), sponsored by Spyre Therapeutics, Inc. Primary endpoint: Treatment emergent adverse events at Week 54. Started Apr 2023; status: terminated.

02

Design

1 arm
Study design
Non-randomizedOpen-label
  • Pegzilarginase

    Weekly subcutaneous dosing of pegzilarginase plus individualized disease management

03

Who it enrols

Patients with Arginase 1 Deficiency who have previously enrolled in pegzilarginase clinical studies.

04

Endpoints

Primary

  • Treatment emergent adverse events

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