MedTrace Logo

Extension Study Evaluating Long Term Safety and Activity of AGT-181 in Children With MPS I

NCT03071341 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2023-03-15

No results posted yet for this study

Summary

AGT-181 is a fusion protein containing alpha-L-iduronidase that is intended to deliver the enzyme peripherally and to the brain, when administered intravenously.

This is a long term safety and tolerability study of AGT-181 in patients with MPS I who completed the previous 26-week study, AGT-181-101. Information on the biological activity of the investigational drug will also be collected.

Conditions

  • Mucopolysaccharidosis I

Interventions

DRUG

AGT-181

Human Insulin Receptor Monoclonal Antibody-Human alpha-L-iduronidase (HIRMAb-IDUA) Fusion Protein

Sponsors & Collaborators

  • ArmaGen, Inc

    lead INDUSTRY

Principal Investigators

  • Patrice P Rioux, MD PhD · ArmaGen, Inc

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2018-02-01
Completion
2018-02-01
FDA Drug
Yes

Countries

  • Brazil

Study Locations

More Related Trials

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 NCT03071341 on ClinicalTrials.gov