Mucopolysaccharidosis VII Disease Monitoring Program (MPS VII DMP)

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

The objectives of this study are to characterize MPS VII disease presentation and progression and assess long-term effectiveness and safety, including hypersensitivity reactions and immunogenicity of vestronidase alfa.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• Diagnosis of MPS VII based on laboratory diagnosis, including either enzymatic or mutation analysis.

• Willing and able to provide written informed consent or, in the case of patients under the age of 18 (or below adult ages as defined by local laws and regulations) or patients \>18 years of age who have cognitive deficiencies, provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the DMP has been explained, and prior to any research-related procedures.

• Willing to comply with DMP visit schedule.

Locations
United States
California
Children's Hospital of Orange County
RECRUITING
Orange
Washington, D.c.
Children's National Health System
RECRUITING
Washington D.c.
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Michigan
University of Michigan
RECRUITING
Ann Arbor
New York
New York University Langone Medical Center
TERMINATED
New York
Utah
University of Utah Medical Center
RECRUITING
Salt Lake City
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Other Locations
Argentina
Laboratorio de Neuroquimica Dr. N.A. Chamoles S.R.L.
RECRUITING
Buenos Aires
Brazil
Hospital de Clínicas de Porto Alegre
RECRUITING
Porto Alegre
France
Centre Hospitalier Universitaire La Timone
RECRUITING
Marseille
Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
RECRUITING
Mainz
Netherlands
Erasmus University Medical Center Rotterdam
TERMINATED
Rotterdam
Portugal
Centro Hospitalar do Porto
RECRUITING
Porto
Spain
Hospital Universitario Virgen del Rocío Pabellón Infantil
RECRUITING
Seville
Contact Information
Primary
Patients Contact: Trial Recruitment
trialrecruitment@ultragenyx.com
1-888-756-8657
Backup
HCPs Contact: Medical Information
medinfo@ultragenyx.com
1-888-756-8657
Time Frame
Start Date: 2018-01-29
Estimated Completion Date: 2033-05
Participants
Target number of participants: 50
Treatments
Patients with MPS VII receiving vestronidase-alfa
via prescription, or early access/ compassionate use program
Patients with MPS VII not receiving vestronidase-alfa
no treatment or treatment other than vestronidase alfa
Sponsors
Leads: Ultragenyx Pharmaceutical Inc

This content was sourced from clinicaltrials.gov

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