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Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

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

NCT00146770•Genzyme, a Sanofi Company

View on ClinicalTrials.gov

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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 (who received 21 of 26 consecutive weekly infusions).
•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 30 days 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 (25)

University of South Alabama

Mobile, Alabama, United States

Emory University School of Medicine

Atlanta, Georgia, United States

University of Rochester

Rochester, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Toledo Children's Hospital

Toledo, Ohio, United States

Merle West Medical Center

Klamath Falls, Oregon, United States

The Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Hospital Universatario de Universidade Federal de Santa Catarina

Florianópolis, Brazil

Hospital Infantil Joana de Gusmao

Florianópolis, Brazil

Key Dates

Start Date

May 1, 2001

Primary Completion Date

March 1, 2005

Completion Date

March 1, 2005

Last Updated

April 3, 2015

Enrollment

ACTUAL participants

Conditions

Mucopolysaccharidosis IHurler's SyndromeHurler-Scheie SyndromeScheie Syndrome

Interventions

Aldurazyme

BIOLOGICAL

Aldurazyme

BIOLOGICAL

placebo

BIOLOGICAL

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AdrenoleukodystrophyBatten Disease+10 more

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ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

Gene Therapy With Modified Autologous Hematopoietic Stem Cells for the Treatment of Patients With Mucopolysaccharidosis Type I, Hurler Variant

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Mucopolysaccharidosis IH

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 3, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

UCB Transplant of Inherited Metabolic Diseases With Administration of Intrathecal UCB Derived Oligodendrocyte-Like Cells

Gene Therapy With Modified Autologous Hematopoietic Stem Cells for the Treatment of Patients With Mucopolysaccharidosis Type I, Hurler Variant

A Study to Evaluate the Safety, Tolerability, PK and PD of Intracerebroventricular GC1123 in Patients with MPS Ⅱ

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