Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase
Public ClinicalTrials.gov record NCT00630747. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
An Open-Label Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Iduronate-2-Sulfatase Enzyme Replacement Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00630747
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2, Phase 3
- Enrollment
- 94 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years and older
- Sex
- Male
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 12, 2004
- Primary completion
- Jan 30, 2008
- Completion
- Jan 30, 2008
- Last update posted
- Jun 9, 2021
2004 – 2008
United States locations
- U.S. sites
- 16
- U.S. states
- 16
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| St. Joseph's Hospital | Phoenix | Arizona | 85013 | — |
| Pediatric Clinical Research Center, Children's Hospital Oakland | Oakland | California | 94609 | — |
| The Children's Hospital | Denver | Colorado | 80218 | — |
| Harbin Clinic | Rome | Georgia | 30165 | — |
| Mid-Illinois Hematology and Oncology Associates | Normal | Illinois | 61761 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Children's Hospital Boston | Boston | Massachusetts | 02115 | — |
| Saint Louis University Cardinal Glennon Children's Hospital | St Louis | Missouri | 63104 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | 89109 | — |
| Upstate Medical University, State University of New York (SUNY) | Syracuse | New York | 13210 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | — |
| Baylor College of Medicine Texas Children's Hospital | Houston | Texas | 77030 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84113 | — |
| Franciscan Skemp Healthcare | La Crosse | Wisconsin | 54601 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 36 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00630747, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 9, 2021 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00630747 live on ClinicalTrials.gov.