A Clinical Assessment Study of Subjects With Mucopolysaccharidosis IVA (Morquio Syndrome)

NCT ID: NCT00787995

Last Updated: 2014-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

353 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2014-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This multicenter, multinational, longitudinal study will quantify endurance and respiratory function in subjects diagnosed with MPS IVA and will better characterize the spectrum of symptoms and biochemical abnormalities in MPS IVA disease over time.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

MPS IV A Mucopolysaccharidosis IVA Morquio A Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Mucopolysaccharidosis IV type A MPS IV Type A Mucopolysaccharidosis IVA MPS IVA Morquio A Syndrome Lysosomal Storage Disorder LSD N-acetylgalactosamine-6-sulfatase galactose-6-sulfatase GALNS enzyme replacement therapy ERT

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MPS IVA

Subjects with mucopolysaccharidosis IVA (Morquio Syndrome)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Willing and able to provide written, signed informed consent, or in the case of subjects age \< 18 years, provide written assent (if required) and written informed consent by a legally authorized representative after the nature of the study has been explained, and prior to any research-related procedures.
* Documented history of reduced GALNS activity relative to the normal range of the laboratory performing the assay, or documented result of molecular genetic testing confirming diagnosis of MPS IVA.
* Willing and able to comply with all study procedures.

Exclusion Criteria

* Use of any investigational product or investigational medical device within 30 days prior to screening.
* Previous hematopoietic stem cell transplant (HSCT).
* Concurrent disease or condition that would interfere with study participation or pose a safety concern.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

BioMarin Pharmaceutical

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Celeste Decker, MD

Role: STUDY_DIRECTOR

BioMarin Pharmaceutical

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oakland, California, United States

Site Status

Chicago, Illinois, United States

Site Status

Córdoba, , Argentina

Site Status

Porto Alegre, , Brazil

Site Status

São Paulo, , Brazil

Site Status

Montreal, Quebec, Canada

Site Status

Lyon, , France

Site Status

Paris, , France

Site Status

Mainz, , Germany

Site Status

Monza, , Italy

Site Status

Amsterdam, , Netherlands

Site Status

Taipei, , Taiwan

Site Status

Birmingham, , United Kingdom

Site Status

London, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Brazil Canada France Germany Italy Netherlands Taiwan United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

Martell LA, Cunico RL, Ohh J, Fulkerson W, Furneaux R, Foehr ED. Validation of an LC-MS/MS assay for detecting relevant disaccharides from keratan sulfate as a biomarker for Morquio A syndrome. Bioanalysis. 2011 Aug;3(16):1855-66. doi: 10.4155/bio.11.172.

Reference Type DERIVED
PMID: 21877895 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.bmrn.com

BioMarin Pharmaceutical Inc. website

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MOR-001

Identifier Type: -

Identifier Source: org_study_id