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NCT00630747 · ClinicalTrials.gov registry record · Phase 2
Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
NCT00630747 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 94 participants.
The verdict
NCT00630747, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
Study Summary
Study TKT024EXT was a long-term, single-arm, open-label extension of Study TKT024, a one year Phase 2/Phase 3 registration study. The primary objective of this extension study was to collect long-term safety and clinical outcome data in Mucopolysaccharidosis II (MPS II), also known as Hunter Syndrome, from the Phase 2/Phase 3 Study TKT024. All patients enrolling into this study received weekly active treatment with idursulfase, the primary dosing regimen investigated in Study TKT024. Hunter Syndrome is an X-linked recessive lysosomal storage disease caused by a deficiency of iduronate-2-sulfatase, an enzyme required to catabolize glycosaminoglycans (GAGS) in cells. As a result, GAGs accumulate in the lysosomes leading to cellular engorgement, organomegaly, tissue destruction, and organ system dysfunction. Hunter Syndrome is a rare disease with an estimated incidence of 1 in 162,000 live births.
Interventions
- BIOLOGICAL Idursulfase
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2004-09-13 |
| Est. Completion | 2008-01-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00630747
The ClinicalTrials.gov registry entry for NCT00630747 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Shire, which has 245 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Idursulfase is the first listed.
NCT00630747 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00630747 about?
NCT00630747 is a clinical study titled "Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase". Study TKT024EXT was a long-term, single-arm, open-label extension of Study TKT024, a one year Phase 2/Phase 3 registration study. The primary objective of this extension study was to collect long-term safety and clinical outcome data in Mucopolysaccharidosis II (MPS II), also known as Hunter Syndrom...
What is the current status of trial NCT00630747?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2004-09-13. Estimated completion is 2008-01-31.
What interventions are being tested in trial NCT00630747?
The interventions under investigation include: Idursulfase (BIOLOGICAL).
Who is sponsoring clinical trial NCT00630747?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
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