Status:
COMPLETED
Extension of Study TKT024 Evaluating Long-Term Safety and Clinical Outcomes in MPS II Patients Receiving Idursulfase
Lead Sponsor:
Shire
Conditions:
Hunter Syndrome
Mucopolysaccharidosis II (MPS II)
Eligibility:
MALE
5+ years
Phase:
PHASE2
PHASE3
Brief 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...
Detailed Description
Study TKT024EXT was conducted in 2 phases. The first phase ("Phase I") was 2 years (104 weeks) in duration and consisted of weekly infusions of IV idursulfase (0.5 mg/kg), and the collection of patien...
Eligibility Criteria
Inclusion
- Patient must have completed the double-blind phase of Study TKT024, defined as completing the Week 53 final evaluations.
- Patient, patient's parent(s), or legally authorized representative must have voluntarily signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient.
Exclusion
- Patient has received treatment with an investigational therapy other than iduronate-2-sulfatase in Study TKT024 within the past 60 days.
- Patient is unable to comply with the protocol (e.g., due to a medical condition such as cervical cord compression or uncooperative attitude) or is unlikely to complete the study, as determined by the investigator.
- Patient has experienced an adverse reaction to study drug in Study TKT024, which contraindicates further treatment with idursulfase.
- Patient with known hypersensitivity to any of the components of idursulfase.
Key Trial Info
Start Date :
September 13 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2008
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00630747
Start Date
September 13 2004
End Date
January 31 2008
Last Update
June 10 2021
Active Locations (52)
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1
St. Joseph's Hospital
Phoenix, Arizona, United States, 85013
2
Pediatric Clinical Research Center, Children's Hospital Oakland
Oakland, California, United States, 94609
3
The Children's Hospital
Denver, Colorado, United States, 80218
4
Harbin Clinic
Rome, Georgia, United States, 30165