Mucopolysaccharidosis I (MPS I) Registry

March 15, 2024 updated by: Genzyme, a Sanofi Company

The Mucopolysaccharidosis I (MPS I) Registry is an ongoing, observational database that tracks the outcomes of patients with MPS I. The data collected by the MPS I Registry will provide information to better characterize the natural history and progression of MPS I as well as the clinical responses of patients receiving enzyme replacement therapy, such as Aldurazyme (Recombinant Human Alpha-L-Iduronidase), or other treatment modalities.

The objectives of the Registry are:

To evaluate the long-term effectiveness and safety of Aldurazyme® (laronidase)
To characterize and describe the MPS I population as a whole, including the variability, progression, and natural history of MPS I
To help the MPS I medical community with the development of recommendations for monitoring patients and reports on patient outcomes to optimize patient care

Study Overview

Status

Recruiting

Conditions

Mucopolysaccharidosis I (MPS I)

Detailed Description

The MPS I Registry is an international program; in addition to the central contact information provided under the "Location" heading, patients may contact:

In Asia-Pacific - Vivian Liu, +65-6431-2548, Vivian.liu@genzyme.com
In Europe - +31-35-699-1232, europe@mpsiregistry.com
In Latin America - +617-591-5500, help@mpsiregistry.com
In North America - +617-591-5500, help@mpsiregistry.com

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: MPS I Registry HelpLine
Phone Number: 617-591-5500
Email: help@MPSIRegistry.com

Study Contact Backup

Name: For site information, send an email with site number to
Email: Contact-Us@sanofi.com

Study Locations

Argentina
- - Buenos Aires, Argentina, 1629
    - Recruiting
    - Investigational Site Number : 153130
- Buenos Aires
  - Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina, 1425
    - Recruiting
    - Investigational Site Number : 153032
Australia
- New South Wales
  - Westmead, New South Wales, Australia, 2145
    - Recruiting
    - Investigational Site Number : 151069
- Queensland
  - Brisbane, Queensland, Australia, 4101
    - Recruiting
    - Investigational Site Number : 152096
Belgium
- - Brussel, Belgium, 1090
    - Recruiting
    - Investigational Site Number : 150944
  - Bruxelles, Belgium, 1200
    - Recruiting
    - Investigational Site Number : 150517
  - Leuven, Belgium, 3000
    - Recruiting
    - Investigational Site Number : 151668
  - Roeselare, Belgium, 8800
    - Recruiting
    - Investigational Site Number : 154008
Brazil
- - Rio de Janeiro, Brazil, 22250020
    - Recruiting
    - Instituto Fernandes Figueira - FIOCRUZ Site Number : 076004
  - São Paulo, Brazil, 04020-041
    - Recruiting
    - Instituto de Genética e Erros Inatos do Metabolismo - IGEIM Site Number : 076002
- Rio Grande Do Sul
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
    - Recruiting
    - Centro de Pesquisa Clínica Prédio 21, 2o andar Hospital de Clínicas de Porto Alegre Site Number : 076001
- São Paulo
  - Campinas, São Paulo, Brazil, 13059-900
    - Recruiting
    - PUC Campinas - Sociedade Campineira de Educaçao e Instruçao Site Number : 076007
Canada
- New Brunswick
  - Moncton, New Brunswick, Canada, E1C2Z3
    - Recruiting
    - Investigational Site Number : 124022
Chile
- - Los Angeles, Chile
    - Recruiting
    - Investigational Site Number : 152003
  - Talcahuano, Chile
    - Recruiting
    - Investigational Site Number : 152001
Colombia
- - Bogotá, Colombia
    - Recruiting
    - Investigational Site Number : 170001
Croatia
- - Zagreb, Croatia, 10000
    - Recruiting
    - Investigational Site Number : 1910001
Czechia
- - Praha 2, Czechia, 12808
    - Recruiting
    - Investigational Site Number : 150659
Denmark
- - København Ø, Denmark, 2100
    - Recruiting
    - Investigational Site Number : 151229
Egypt
- - Cairo, Egypt, 12622
    - Recruiting
    - Investigational Site Number : 818002
  - Cairo, Egypt
    - Recruiting
    - Investigational Site Number : 818001
France
- - BRON Cedex, France, 69677
    - Recruiting
    - Investigational Site Number : 250001
  - Marseille Cedex 05, France, 13385
    - Completed
    - Investigational Site Number : 250002
  - Paris, France, 75015
    - Recruiting
    - Investigational Site Number : 250003
  - Paris Cedex 12, France, 75571
    - Recruiting
    - Investigational Site Number : 250005
  - Vandoeuvre Les Nancy Cedex, France, 54511
    - Completed
    - Investigational Site Number : 250006
Hong Kong
- - Kowloon, Hong Kong
    - Recruiting
    - Investigational Site Number : 344001
Hungary
- - Pécs, Hungary, 7623
    - Recruiting
    - Investigational Site Number : 3480005
India
- - Ahmedabad, India, 380015
    - Recruiting
    - Investigational Site Number : 356003
  - Kolkata, India, 700017
    - Recruiting
    - Investigational Site Number : 356001
  - Secunderabad, India, 500026
    - Recruiting
    - Investigational Site Number : 3560004
  - Vellore, India, 632004
    - Recruiting
    - Investigational Site Number : 356002
Indonesia
- - Jakarta, Indonesia
    - Recruiting
    - Investigational Site Number : 360001
Italy
- - Ancona, Italy, 60126
    - Completed
    - Investigational Site Number : 380002
  - Cusano Milanino, Italy
    - Recruiting
    - Investigational Site Number : 380004
  - Firenze, Italy, 50141
    - Recruiting
    - Investigational Site Number : 380009
  - Genova, Italy, 16147
    - Recruiting
    - Investigational Site Number : 380003
  - Milano, Italy, 20142
    - Completed
    - Investigational Site Number : 380007
  - Napoli, Italy
    - Recruiting
    - Investigational Site Number : 380005
  - Padova, Italy, 35128
    - Recruiting
    - Investigational Site Number : 380008
  - Roma, Italy, 00165
    - Recruiting
    - Investigational Site Number : 380006
  - Udine, Italy
    - Recruiting
    - Investigational Site Number : 380001
Japan
- Kochi
  - Nangoku-shi, Kochi, Japan, 783-0043
    - Recruiting
    - Investigational Site Number : 392102
- Tokyo
  - Setagaya, Tokyo, Japan, 157-0074
    - Recruiting
    - Investigational Site Number : 392101
Korea, Republic of
- - Daejeon, Korea, Republic of
    - Recruiting
    - Investigational Site Number : 153191
  - Jeonnam, Korea, Republic of
    - Recruiting
    - Investigational Site Number : 153225
  - Seoul, Korea, Republic of, 03080
    - Recruiting
    - Investigational Site Number : 153180
  - Seoul, Korea, Republic of, 04401
    - Recruiting
    - Investigational Site Number : 153192
  - Seoul, Korea, Republic of, 05505
    - Recruiting
    - Investigational Site Number : 151149
  - Seoul, Korea, Republic of
    - Recruiting
    - Investigational Site Number : 153212
  - Seoul, Korea, Republic of
    - Recruiting
    - Investigational Site Number : 153222
  - Seoul, Korea, Republic of, 03080
    - Recruiting
    - Investigational Site Number : 153196
- Gyeongsangnam-do
  - Changwon-si, Gyeongsangnam-do, Korea, Republic of, 51353
    - Recruiting
    - Investigational Site Number : 154286
  - Yangsan, Gyeongsangnam-do, Korea, Republic of, 50612
    - Recruiting
    - Investigational Site Number : 154148
  - Yangsan-si, Gyeongsangnam-do, Korea, Republic of, 50612
    - Recruiting
    - Investigational Site Number : 153178
Kuwait
- - Kuwait, Kuwait
    - Recruiting
    - Investigational Site Number : 154225
Lebanon
- - Beirut, Lebanon, 11072210
    - Recruiting
    - Investigational Site Number : 4220004
Malaysia
- - Jalan Pahang, Malaysia, 50586
    - Recruiting
    - Investigational Site Number : 458001
  - Kuala Lumpur, Malaysia, 59100
    - Recruiting
    - Investigational Site Number : 458002
Netherlands
- - Amsterdam, Netherlands
    - Completed
    - Investigational Site Number : 151171
  - Rotterdam, Netherlands, 3015GD
    - Recruiting
    - Investigational Site Number : 152029
Pakistan
- - Lahore, Pakistan
    - Recruiting
    - Investigational Site Number : 154266
  - Lahore, Pakistan
    - Recruiting
    - Investigational Site Number : 154264
Philippines
- - Manila, Philippines, 1000
    - Recruiting
    - Investigational Site Number : 608001
Poland
- - Warszawa, Poland, 04-730
    - Recruiting
    - Investigational Site Number : 150575
Portugal
- - Coimbra, Portugal, 3000-075
    - Recruiting
    - Investigational Site Number : 6200002
Romania
- - Cluj Napoca, Romania, 400370
    - Recruiting
    - Investigational Site Number : 154177
Russian Federation
- - Moscow, Russian Federation, 119571
    - Recruiting
    - Investigational Site Number : 643001
  - Moscow, Russian Federation, 125412
    - Recruiting
    - Investigational Site Number : 643002
Saudi Arabia
- - Makkah, Saudi Arabia, 21955
    - Recruiting
    - Investigational Site Number : 682004
  - Qatif, Saudi Arabia
    - Recruiting
    - Investigational Site Number : 682001
Singapore
- - Singapore, Singapore, 229899
    - Recruiting
    - Investigational Site Number : 702001
Slovakia
- - Bratislava, Slovakia, 83340
    - Recruiting
    - Investigational Site Number : 703001
Taiwan
- - Chiayi, Taiwan
    - Recruiting
    - Investigational Site Number : 154093
  - Hualien, Taiwan
    - Recruiting
    - Investigational Site Number : 152152
  - Kaohsiung, Taiwan, 807
    - Recruiting
    - Investigational Site Number : 152244
  - Kaohsiung Hsien,, Taiwan
    - Recruiting
    - Investigational Site Number : 152246
  - New Taipei City, Taiwan, 23142
    - Recruiting
    - Investigational Site Number : 151534
  - Putz City, Chia-yi, Taiwan
    - Recruiting
    - Investigational Site Number : 151500
  - Taichung, Taiwan, 00407
    - Recruiting
    - Investigational Site Number : 151181
  - Taichung City, Taiwan, 404
    - Recruiting
    - Investigational Site Number : 151179
  - Tainan, Taiwan, 70403
    - Recruiting
    - Investigational Site Number : 153248
  - Tainan, Taiwan
    - Recruiting
    - Investigational Site Number : 152153
  - Taipei, Taiwan, 10041
    - Recruiting
    - Investigational Site Number : 151182
  - Taipei, Taiwan, 10449
    - Recruiting
    - Investigational Site Number : 152321
  - Tao Yuan County, Taiwan
    - Recruiting
    - Investigational Site Number : 153158
Thailand
- - Bangkok, Thailand, 10400
    - Completed
    - Investigational Site Number : 764002
  - Bangkok, Thailand, 10400
    - Recruiting
    - Investigational Site Number : 764003
  - Bangkok, Thailand, 10700
    - Recruiting
    - Investigational Site Number : 764004
  - Bangkok, Thailand
    - Recruiting
    - Investigational Site Number : 764001
  - Khon Kaen, Thailand, 40002
    - Recruiting
    - Investigational Site Number : 764005
United Kingdom
- - Birmingham, United Kingdom, B152TH
    - Recruiting
    - Investigational Site Number : 152287
  - Birmingham, United Kingdom, B46NH
    - Recruiting
    - Investigational Site Number : 154240
  - London, United Kingdom, WC1N3BG
    - Recruiting
    - Investigational Site Number : 151646
United States
- Arkansas
  - Little Rock, Arkansas, United States, 72202
    - Recruiting
    - Arkansas Childrens Hospital Site Number : 840109
- California
  - Los Angeles, California, United States, 90027
    - Recruiting
    - Southern California Permanente Medical Group Site Number : 840108
  - Oakland, California, United States, 94609
    - Completed
    - Children's Hospital Oakland Site Number : 840029
  - San Bernardino, California, United States, 92408
    - Recruiting
    - Loma Linda University Children's Hospital Site Number : 840117
  - San Diego, California, United States, 92093
    - Completed
    - University of California at San Diego Site Number : 840007
- Colorado
  - Aurora, Colorado, United States, 80045
    - Completed
    - Children's Hospital IMD Clinic Site Number : 840069
- Connecticut
  - New Haven, Connecticut, United States, 06520
    - Recruiting
    - Yale Site Number : 840047
- District of Columbia
  - Washington, District of Columbia, United States, 20010
    - Recruiting
    - Children's National Medical Center Site Number : 840067
- Florida
  - Gainesville, Florida, United States, 32610
    - Recruiting
    - University of Florida Dept of Genetics Site Number : 840083
  - Jacksonville, Florida, United States, 32207
    - Recruiting
    - University of Florida Pediatrics Genetics Site Number : 840121
  - Jacksonville, Florida, United States, 32216
    - Recruiting
    - The Atwal Clinic Site Number : 840112
- Illinois
  - Chicago, Illinois, United States, 60611
    - Recruiting
    - Ann and Robert Lurie Children's Hospital Site Number : 840011
- Indiana
  - Indianapolis, Indiana, United States, 46202
    - Recruiting
    - Indianapolis University School of Medicine Site Number : 840027
- Iowa
  - Iowa City, Iowa, United States, 52242
    - Recruiting
    - University of Iowa Site Number : 840032
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Recruiting
    - University of Louisville- Genetics Site Number : 840030
- Louisiana
  - New Orleans, Louisiana, United States, 70121
    - Recruiting
    - Ochsner Medical Center Site Number : 840120
- Maryland
  - Baltimore, Maryland, United States
    - Recruiting
    - John Hopkins Site Number : 840044
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Recruiting
    - Massachusetts General Hospital-Genetics Site Number : 840062
  - Boston, Massachusetts, United States, 2115
    - Recruiting
    - Boston Children's Hospital Site Number : 840093
  - Springfield, Massachusetts, United States, 01199
    - Recruiting
    - Baystate Health Site Number : 840002
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Recruiting
    - University of Michigan Pediatrics Site Number : 840107
- Minnesota
  - Minneapolis, Minnesota, United States, 55404
    - Recruiting
    - Children's Health Care Site Number : 840114
- Missouri
  - Saint Louis, Missouri, United States, 63110
    - Recruiting
    - Washington University of St. Louis Site Number : 840100
- Nebraska
  - Omaha, Nebraska, United States, 68198
    - Recruiting
    - University of Nebraska Medical Center- Pediatrics Site Number : 840084
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Recruiting
    - Joseph M. Sanzari Children's Hospital Site Number : 840101
  - Morristown, New Jersey, United States, 07960
    - Recruiting
    - Atlantic Health System Site Number : 840099
  - New Brunswick, New Jersey, United States, 08901
    - Recruiting
    - St. Peter's University Hospital Site Number : 840016
  - Paterson, New Jersey, United States, 07503
    - Recruiting
    - St. Joseph's Children's Hospital Site Number : 840057
- New York
  - Manhasset, New York, United States, 11030
    - Recruiting
    - Northwell Health Site Number : 840102
  - New York, New York, United States, 10016
    - Recruiting
    - New York University School Of Medicine Site Number : 840040
  - New York, New York, United States, 10029-7494
    - Recruiting
    - Metropolitan Hospital Center Site Number : 840110
  - Rochester, New York, United States, 14642
    - Recruiting
    - University of Rochester Medical Center SOM Site Number : 840105
  - Syracuse, New York, United States, 13210
    - Recruiting
    - State University of New York Site Number : 840052
- North Carolina
  - Durham, North Carolina, United States, 27710
    - Recruiting
    - Duke University Medical Center Genetics Dept Site Number : 840037
- Ohio
  - Cincinnati, Ohio, United States
    - Recruiting
    - Cincinnati Children's Hospital-Genetics Site Number : 840041
  - Cleveland, Ohio, United States, 44106
    - Recruiting
    - UHCMC Site Number : 840119
  - Columbus, Ohio, United States, 43205-2664
    - Recruiting
    - Nationwide Children's Hospital Site Number : 840091
  - Dublin, Ohio, United States, 43017
    - Recruiting
    - LSD Data Registry Site LLC Site Number : 840094
- Oregon
  - Portland, Oregon, United States, 97239
    - Recruiting
    - Oregon Health & Science University Site Number : 840080
- Pennsylvania
  - Philadelphia, Pennsylvania, United States
    - Recruiting
    - Children's Hospital of Philadelphia Site Number : 840034
  - Pittsburgh, Pennsylvania, United States, 15224
    - Recruiting
    - University of Pittsburgh Site Number : 840023
- Rhode Island
  - Providence, Rhode Island, United States, 02903
    - Recruiting
    - Rhode Island Hospital Genetics Site Number : 840053
- South Carolina
  - Greenville, South Carolina, United States, 29605
    - Recruiting
    - Greenwood Genetcs Site Number : 840055
- Virginia
  - Charlottesville, Virginia, United States, 22908
    - Recruiting
    - University of Virginia School of Medicine-Pediatrics Site Number : 840078
  - Norfolk, Virginia, United States, 23507
    - Recruiting
    - Children's Hospital of the Kings Daughters Site Number : 840072
- Washington
  - Tacoma, Washington, United States, 98415
    - Recruiting
    - Multicare Health System ¿ Mary Bridge Childrens Hospital Site Number : 840115
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Recruiting
    - Children's Hospital of Wisconsin-Pediatrics Site Number : 840054
Vietnam
- - Hanoi, Vietnam
    - Recruiting
    - Investigational Site Number : 154212
  - Ho Chi Minh City, Vietnam, 700000
    - Recruiting
    - Investigational Site Number : 704002

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

All Patients with MPS I

Description

Inclusion Criteria:

All patients with a confirmed diagnosis of MPS I are eligible for inclusion. Confirmed diagnosis is defined as: A. documented biochemical evidence of a deficiency in alpha (a)-L-iduronidase enzyme activity and/or B. mutation(s) in the gene coding for a-L-iduronidase, or measurable clinical signs and symptoms of MPS I
For all patients there should be a completed patient authorization form

Exclusion Criteria:

No exclusion criteria for participation in the MPS I Registry. NOTE: Registry participation does not exclude participation in other clinical studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To evaluate the long-term effectiveness of Aldurazyme Time Frame: Approximately 17 Years	Approximately 17 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Investigators

Study Director: Medical Monitor, Genzyme, a Sanofi Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2003

Primary Completion (Estimated)

January 31, 2034

Study Completion (Estimated)

January 31, 2034

Study Registration Dates

First Submitted

September 2, 2005

First Submitted That Met QC Criteria

September 2, 2005

First Posted (Estimated)

September 5, 2005

Study Record Updates

Last Update Posted (Actual)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 15, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

DIREGC07008 (Sanofi)
U1111-1294-8266 (Registry Identifier: ICTRP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Mucopolysaccharidosis I (MPS I) Registry

Study Overview

Status

Conditions

Detailed Description

Study Type

Enrollment (Estimated)

Contacts and Locations

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimated)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Mucopolysaccharidosis I (MPS I)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Qatar

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations