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NCT00299000 · ClinicalTrials.gov registry record · Phase 4
A Phase 4 Two Dose Level Study of Naglazyme(TM) (Galsulfase) in Infants With MPS VI
A Phase 4 study of Mucopolysaccharidosis VI and Maroteaux Lamy Syndrome, sponsored by BioMarin Pharmaceutical.
- Completed
- Registry status
- Phase 4
- Development phase
- 4
- Enrollment target
- 4
- Study locations
NCT00299000: Completed Phase 4 study of Mucopolysaccharidosis VI and Maroteaux Lamy Syndrome, sponsored by BioMarin Pharmaceutical.
NCT00299000 is a Phase 4 study of Mucopolysaccharidosis VI and Maroteaux Lamy Syndrome that has completed, run by BioMarin Pharmaceutical. The registered enrollment target is 4 participants, below the 68-participant average among 6 other Mucopolysaccharidosis VI trials with a reported enrollment target (94% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00299000, a Phase 4 study of Mucopolysaccharidosis VI and Maroteaux Lamy Syndrome, has completed, sponsored by BioMarin Pharmaceutical.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 4 participants
- Enrollment target
- 4
- Study locations
Study Summary
The purpose of the study is to evaluate the safety and efficacy of two dose levels of Naglazyme in infants under the age of one year who have MPS VI by monitoring physical appearance, x-ray of the skeletal system and growth.
Conditions Studied
Interventions
- DRUG Naglazyme
Study Locations (4)
California
- Children's Hospital Los Angeles - Los Angeles
- Children's Hospital Oakland - Oakland
Other
- Hospital Femme Mere Enfant Centre - Lyon
- Hospital PediAtrico de Coimbra - Coimbra
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2006-05 |
| Est. Completion | 2009-04 |
| Phase | Phase 4 |
What the finished NCT00299000 record still lists
NCT00299000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 68-participant average among 6 other Mucopolysaccharidosis VI trials with a reported enrollment target (94% lower).
The record links to 2 conditions, with Mucopolysaccharidosis VI appearing as the primary indexed condition, and to 1 intervention - of which Naglazyme is the first listed.
NCT00299000 reports a single indexed study location in California, Other.
Frequently Asked Questions
What is clinical trial NCT00299000 about?
NCT00299000 is a clinical study titled "A Phase 4 Two Dose Level Study of Naglazyme(TM) (Galsulfase) in Infants With MPS VI". The purpose of the study is to evaluate the safety and efficacy of two dose levels of Naglazyme in infants under the age of one year who have MPS VI by monitoring physical appearance, x-ray of the skeletal system and growth.
What is the current status of trial NCT00299000?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 4 participants. The study started on 2006-05. Estimated completion is 2009-04.
What conditions does trial NCT00299000 study?
This clinical trial studies the following conditions: Mucopolysaccharidosis VI, Maroteaux Lamy Syndrome.
What interventions are being tested in trial NCT00299000?
The interventions under investigation include: Naglazyme (DRUG).
Who is sponsoring clinical trial NCT00299000?
This trial is sponsored by BioMarin Pharmaceutical, which has 80 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00299000 being conducted?
This trial has 4 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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