Status:
COMPLETED
Phase 3 Extension Study of the Safety and Efficacy of Aldurazyme® (Laronidase) in Mucopolysaccharidosis I (MPS I) Patients
Lead Sponsor:
Genzyme, a Sanofi Company
Collaborating Sponsors:
BioMarin/Genzyme LLC
Conditions:
Mucopolysaccharidosis I
Hurler's Syndrome
Eligibility:
All Genders
Phase:
PHASE3
Brief 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 Dou...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00146770
Start Date
May 1 2001
End Date
March 1 2005
Last Update
April 3 2015
Active Locations (25)
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1
University of South Alabama
Mobile, Alabama, United States, 36604
2
Emory University School of Medicine
Atlanta, Georgia, United States, 30322
3
University of Rochester
Rochester, New York, United States, 14542
4
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599