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

• Status: Completed
• Trial end date: 2018-08-02
• Target enrollment: 0
• Participant gender: All

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 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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ArmaGen, Inc
• Treatments: Antibodies; Antibodies, Monoclonal; Insulin; Insulin, Globin Zinc

Criteria

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