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Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients

Information source: Genzyme
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Mucopolysaccharidosis I; Hurler's Syndrome; Hurler-Scheie Syndrome; Scheie Syndrome

Intervention: Aldurazyme (Recombinant Human Alpha-L-Iduronidase) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Genzyme

Summary

This study is being conducted to collect additional long-term efficacy and safety data of Aldurazyme (Laronidase) patients with MPS I disease. Patients who were previously enrolled in the phase 3 double-blind study will be enrolled in this study.

Clinical Details

Official title: A Multicenter, Multinational, Open-Label Extension Study of the Safety and Efficacy of Aldurazyme (Laronidase) in Patients With Mucopolysaccharidosis I

Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome: To collect additional long-term efficacy and safety data of Aldurazyme (laronidase) on patients previously enrolled in the phase 3 double-blind study.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- The patient or patient’s legal guardian must provide written informed consent prior to

any protocol-related procedures being performed.

- The patient must have successfully completed Study ALID-003-99.

- The patient has not experienced any safety issues that would contraindicate

participation in the Extension study.

- A female patient of childbearing potential must have a negative pregnancy test at

entry

Exclusion Criteria:

- The patient is pregnant or lactating.

- The patient has received an investigational drug within 30days prior to the study

enrollment.

- The patient has a medical condition, serious intercurrent illness, or other

extenuating circumstance that may significantly interfere with study compliance including all prescribed evaluations and follow-up activities

Locations and Contacts

Hospital Infantil Joana de Gusmao, Florianopolis CEP 88025-301, Brazil

Hospital Universatario de Universidade Federal de Santa Catarina, Florianopolis 88040-500, Brazil

Alberta Children's Hospital, Calgary T2T 5C7, Canada

Medizinishe Hochshule Hannover, Hannover 30625, Germany

Children's Hospital at the University Hospital of Heidelberg, Heidelberg 69120, Germany

Children's Hospital Klinikum Nord Heidberg, Hamburg 22143, Germany

Children's Hospital Klinikum der F.S. Universitat, Jena 07740, Germany

Catholic University Sacro Cuore, Rome 00168, Italy

Academisch Ziekenhuis Rotterdam, Rotterdam 3000 GR, Netherlands

Birmingham Children's Hospital, Birmingham B4 6NH, United Kingdom

Gartnavel Hospital, Glasgow G11 6NT, United Kingdom

Bristol Royal Hospital for Children and Frenchay Hospital, Bristol BS16 1LE, United Kingdom

Royal Victoria Hospital, Newcastle upon Tyre NE1 4LB, United Kingdom

Belfast City Hospital, Belfast BT9 78A, United Kingdom

Great Ormond Street Hospital for Sick Children and NHS Trust, London WC1N 3GH, United Kingdom

University of South Alabama, Mobile, Alabama 36604, United States

Emory University School of Medicine, Atlanta, Georgia 30322, United States

Blackpool Victoria Hospital, Blackpool, Lancashire FY3 8NR, United Kingdom

University of Rochester, Rochester, New York 14542, United States

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, United States

Toledo Children's Hospital, Toledo, Ohio 43606, United States

The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada

Merle West Medical Center, Klamath Falls, Oregon 97601, United States

The Childrens Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

Additional Information

US FDA Approved Full Prescribing Information for Aldurazyme®

Link to Results Synopsis for ALID-006-01

Starting date: June 2001
Ending date: March 2005
Last updated: July 16, 2007

Page last updated: June 20, 2008

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