Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
ArmaGen, Inc
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male age 18 years or older
Diagnosis of MPS I (documented fibroblast or leukocyte IDUA enzyme activity level of less than 10% of the lower limit of the normal range of the measuring laboratory)
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)
Must not have received ERT for at least 6 weeks prior to AGT-181 treatment
Must have elevated urinary GAGs if no ERT has been received in the prior 3 months
You may not be if
Refusal to complete baseline evaluations.
Any medical condition or other circumstances that may significantly interfere with study compliance
Receipt of an investigational drug within the prior 90 days
History of diabetes mellitus or hypoglycemia
Clinically significant spinal cord compression, evidence of cervical instability.
Known hypersensitivity to alpha-L-iduronidase or any of the components of AGT-181.
Known to be nonresponsive to standard ERT treatment.
Previously successful (engrafted) hematopoietic stem cell transplantation that resulted in normalization of urinary GAGs.
Contraindication for lumbar puncture
Clareo Health | Safety and Dose Ranging Study of Insulin Receptor MAb-IDUA Fusion Protein in Patients With MPS I
