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COMPLETED Phase 4

A Phase 4 Two Dose Level Study of Naglazyme(TM) (Galsulfase) in Infants With MPS VI

NCT00299000 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 4 participants
Start Date 2006-05
Est. Completion 2009-04
Phase Phase 4

Sponsor

BioMarin Pharmaceutical

31 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00299000

The ClinicalTrials.gov registry entry for NCT00299000 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BioMarin Pharmaceutical, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00299000 reports 4 study locations spanning 2 distinct geographic areas — top geographies include California, Other. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00299000?

The interventions under investigation include: Naglazyme (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00299000?

This trial is sponsored by BioMarin Pharmaceutical, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial