Extension Study of AGT-181-102 to Evaluate Long Term Safety and Activity of AGT-181

ArmaGen, Inc3 enrolled

Overview

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 study is an extension of a safety and dose ranging study to obtain long term safety and exposure data, as well as information on the biological activity of the investigational drug

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Mucopolysaccharidosis I

Interventions

AGT-181DRUG

intravenous infusion over 3-4 hours

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must have completed clinical trial AGT-181-102 * Voluntary written consent by patient or legally responsible representative * All women of childbearing potential and sexually mature males must be advised to use a medically accepted method of contraception throughout the study. * Negative pregnancy test (females) Exclusion Criteria: * Refusal to complete screening evaluations. * Any medical condition or other circumstances that may significantly interfere with study compliance * Patient is pregnant or lactating * Clinically significant spinal cord compression, evidence of cervical instability. * Subject developed clinically relevant hypersensitivity to AGT-181