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RecruitingNCT03604835Updated Aug 27, 2026

Mucopolysaccharidosis VII Disease Monitoring Program

An observational study in Mucopolysaccharidosis VII, MPS VII and MPS 7, sponsored by Ultragenyx Pharmaceutical Inc. Recruiting at 14 sites in 8 countries. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by Ultragenyx Pharmaceutical Inc · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
50
Sex
All
01

Study 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.

Read the detailed description

The Mucopolysaccharidosis VII Disease Monitoring Program (MPS VII DMP) is a global, prospective, multicenter, longitudinal protocol designed to characterize MPS VII disease presentation and progression, assess long-term effectiveness and safety of vestronidase alfa, including hypersensitivity reactions and immunogenicity , as well as prospectively investigate longitudinal change across biomarker(s), clinical assessments, and patient/ caregiver-reported outcome measures in a representative population. The aim of this DMP is to collect data on patients with MPS VII to provide a comprehensive dataset on the clinical presentation, heterogeneity, and disease progression, and meaningful standardized ICH GCP-quality data collected in-clinic across multiple sites globally. The DMP is not a randomized study and both treated and untreated patients will be enrolled.

02

Conditions studied

  • Mucopolysaccharidosis VII
  • MPS VII
  • MPS 7
  • Sly Syndrome

Keywords

  • UX003
  • Mepsevii
  • vestronidase alfa-vjbk
  • vestronidase alfa
  • recombinant human beta-glucuronidase
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with a confirmed diagnosis of MPS VII, including patients who already received vestronidase alfa in an Ultragenyx clinical trial or early access/ compassionate use program, and patients not receiving vestronidase alfa.

Patients who were previously enrolled in an Ultragenyx-sponsored clinical trial may participate in the DMP if they have completed or discontinued from the clinical trial.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Concurrent participation in other pharmaceutical company-sponsored interventional clinical trial unless approved by Ultragenyx.
04

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patients with MPS VII receiving vestronidase-alfa

    via prescription, or early access/ compassionate use program

    Other: No Intervention

  • Patients with MPS VII not receiving vestronidase-alfa

    no treatment or treatment other than vestronidase alfa

    Other: No Intervention

Interventions

  • OtherNo Intervention

    Access to any treatment is through authorized commercial use or available expanded access programs only and not as a part of this DMP.

05

What researchers measure

Primary outcomes

  1. Clinical Course of MPS VII Disease

    To characterize MPS VII disease presentation and progression over time in patients treated and not treated with vestronidase alfa

    Time frame: 10 years

  2. Long-term Effectiveness of Vestronidase Alfa

    To evaluate longitudinal change in biomarker(s), clinical assessments and patient/caregiver reported outcomes to examine the effectiveness of vestronidase alfa

    Time frame: 10 years

  3. Long-term Safety of Vestronidase Alfa

    Hypersensitivity reactions, immunogenicity and other safety outcomes will be assessed to examine the long-term safety of vestronidase alfa.

    Time frame: 10 years

06

Study locations

12 of 14 sites recruiting
  • Children's Hospital of Orange County
    Orange, California 92868, United States
    Recruiting
  • Children's National Health System
    Washington D.C., District of Columbia 20010, United States
    Recruiting
  • Ann & Robert H. Lurie Children's Hospital of Chicago
    Chicago, Illinois 60611, United States
    Recruiting
  • University of Michigan
    Ann Arbor, Michigan 48109, United States
    Recruiting
  • New York University Langone Medical Center
    New York, New York 10016, United States
    Terminated
  • University of Utah Medical Center
    Salt Lake City, Utah 84112, United States
    Recruiting
  • Seattle Children's Hospital
    Seattle, Washington 98105, United States
    Recruiting
  • Laboratorio de Neuroquimica Dr. N.A. Chamoles S.R.L.
    Buenos Aires, Buenos Aires C1425FNG, Argentina
    Recruiting
  • Hospital de Clínicas de Porto Alegre
    Porto Alegre, Rio Grande do Sul 90035-003, Brazil
    Recruiting
  • Centre Hospitalier Universitaire La Timone
    Marseille, Provence-Alpes-Côte d'Azur Region 13005, France
    Recruiting
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    Mainz, 55131, Germany
    Recruiting
  • Erasmus University Medical Center Rotterdam
    Rotterdam, South Holland 3015 CN, Netherlands
    Terminated
  • Centro Hospitalar do Porto
    Porto, 4050-651, Portugal
    Recruiting
  • Hospital Universitario Virgen del Rocío Pabellón Infantil
    Seville, Sevilla 41013, Spain
    Recruiting
07

References and documents

08

Registry details

Key details

Study ID
NCT03604835
Lead sponsor
Ultragenyx Pharmaceutical Inc
Responsible party
Sponsor
First posted
Jul 30, 2018
Start date
Jan 29, 2018
Primary completion
Apr 2032 (estimated)
Completion
Apr 2032 (estimated)
Last update
Aug 27, 2026

Study contacts

Patients Contact: Trial Recruitment
Contact
trialrecruitment@ultragenyx.com
1-888-756-8657
HCPs Contact: Medical Information
Contact
medinfo@ultragenyx.com
1-888-756-8657
Medical Director
study director · Ultragenyx Pharmaceuticals Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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