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Pegzilarginase in Subjects <24 Months Old With Arginase 1 Deficiency

NCT06582524 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2026-05-22

Study results available
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Summary

This is an open-label, multicentre study to evaluate the safety, PK, and activity (PD) of weekly subcutaneous (SC) administration of pegzilarginase in subjects with ARG1-D who are \< 24 months of age. The study consists of a screening period of up to 4 weeks, a subsequent 12-week treatment period, and a safety follow-up period of 8 weeks.

Conditions

  • Arginase 1 Deficiency

Interventions

DRUG

Pegzilarginase

SC administration of pegzilarginase over 12 weeks in subjects with ARG1-D who are \< 24 months of age

Sponsors & Collaborators

  • Immedica Pharma AB

    lead INDUSTRY

Principal Investigators

  • Mattias Rudebeck, PhD MSc BMedSc · Immedica Pharma AB

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
24 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2025-06-17
Completion
2025-06-17

Countries

  • Austria
  • Portugal
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06582524 on ClinicalTrials.gov