Evaluation of Intravenous Laronidase Pharmacokinetics Before and After Hematopoietic Cell Transplantation in Patients With Mucopolysaccharidosis Type IH.

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This is a prospective, observational multicenter study to collect blood from patients with mucopolysaccharidosis type IH undergoing laronidase therapy and a stem cell transplant. Sixteen patients will be enrolled over a 24 month period.

Eligibility
Participation Requirements
Sex: All
Maximum Age: 3
Healthy Volunteers: f
View:

• Between 0 to 3 years of age

‣ Meet protocol specific eligibility criteria for allogeneic HCT for MPS IH

⁃ Planning to receive laronidase both pre and post-transplant in an inpatient setting as part of standard-of-care treatment. Virtually all patients with MPSIH being considered for transplantation at the University of Minnesota are already receiving enzyme infusions, and it is standard practice to continue to give enzyme infusions to 8 weeks post-transplant. Therefore, participation will not modify the treatment course.

Locations
United States
Minnesota
University of Minnesota Masonic Cancer Center
RECRUITING
Minneapolis
Contact Information
Primary
Kim Nelson, RN
knelso62@fiarview.org
612-273-2925
Time Frame
Start Date: 2022-11-17
Estimated Completion Date: 2026-10-01
Participants
Target number of participants: 24
Treatments
Collect blood from patients with MPS-IH) undergoing laronidase therapy and stem cell transplant.
The primary aim is to characterize the PK of IV laronidase in individuals with MPS IH and identify patient specific covariates that impact drug exposure. The secondary aim is to identify key differences pre-and post-HCT leading to variability in PK parameters for patients receiving IV laronidase therapy for the treatment of MPS-IH.
Sponsors
Leads: Masonic Cancer Center, University of Minnesota

This content was sourced from clinicaltrials.gov