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NCT00144768 · ClinicalTrials.gov registry record · Phase 4
A Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary GAG (Glycosaminoglycan) Levels in Aldurazyme® Treated Patients
A Phase 4 study of Mucopolysaccharidosis I and Hurler's Syndrome, sponsored by Genzyme, a Sanofi Company.
- Completed
- Registry status
- Phase 4
- Development phase
- 25
- Enrollment target
- 3
- Study locations
NCT00144768: Completed Phase 4 study of Mucopolysaccharidosis I and Hurler's Syndrome, sponsored by Genzyme, a Sanofi Company.
NCT00144768 is a Phase 4 study of Mucopolysaccharidosis I and Hurler's Syndrome that has completed, run by Genzyme, a Sanofi Company. The registered enrollment target is 25 participants, below the 72-participant average among 5 other Mucopolysaccharidosis I trials with a reported enrollment target (65% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00144768, a Phase 4 study of Mucopolysaccharidosis I and Hurler's Syndrome, has completed, sponsored by Genzyme, a Sanofi Company.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 25 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to determine whether the development of antibodies to laronidase in patients with MPS I receiving Aldurazyme® impairs the clearance of GAG substrate.
Conditions Studied
Interventions
- DRUG laronidase
Study Locations (3)
California
- Childrens Hospital Los Angeles - Los Angles
Connecticut
- Connecticut Children's Medical Center - Hartford
Wisconsin
- Children's Hospital of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2004-07 |
| Est. Completion | 2007-05 |
| Phase | Phase 4 |
What the finished NCT00144768 record still lists
NCT00144768 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 72-participant average among 5 other Mucopolysaccharidosis I trials with a reported enrollment target (65% lower).
The record links to 4 conditions, with Mucopolysaccharidosis I appearing as the primary indexed condition, and to 1 intervention - of which laronidase is the first listed.
NCT00144768 reports a single indexed study location in California, Connecticut, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT00144768 about?
NCT00144768 is a clinical study titled "A Study Investigating the Relationship Between the Development of Laronidase Antibody and Urinary GAG (Glycosaminoglycan) Levels in Aldurazyme® Treated Patients". The purpose of this study is to determine whether the development of antibodies to laronidase in patients with MPS I receiving Aldurazyme® impairs the clearance of GAG substrate.
What is the current status of trial NCT00144768?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 25 participants. The study started on 2004-07. Estimated completion is 2007-05.
What conditions does trial NCT00144768 study?
This clinical trial studies the following conditions: Mucopolysaccharidosis I, Hurler's Syndrome, Hurler-Scheie Syndrome, Scheie's Syndrome.
What interventions are being tested in trial NCT00144768?
The interventions under investigation include: laronidase (DRUG).
Who is sponsoring clinical trial NCT00144768?
This trial is sponsored by Genzyme, a Sanofi Company, which has 196 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00144768 being conducted?
This trial has 3 study locations across California, Connecticut, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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