Extension Study of AGT-181-102 to Evaluate Long Term Safety and Activity of AGT-181
NCT ID: NCT02597114
Last Updated: 2018-09-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
3 participants
INTERVENTIONAL
2015-11-30
2018-08-02
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AGT-181
AGT-181 (fusion protein of anti-human insulin receptor monoclonal antibody and alpha-L-iduronidase) administered once weekly x 26 weeks at same dose level as subject received in core study
AGT-181
intravenous infusion over 3-4 hours
Interventions
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AGT-181
intravenous infusion over 3-4 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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ArmaGen, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Patrice Rioux, MD PhD
Role: STUDY_DIRECTOR
ArmaGen, Inc
Other Identifiers
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AGT-181-103
Identifier Type: -
Identifier Source: org_study_id
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