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
- Conditions
- Mucopolysaccharidosis Type II (MPS II or Hunter Syndrome)MedDRA version: 6.1Level: PTClassification code 10056889
- Registration Number
- EUCTR2004-002743-27-DE
- Lead Sponsor
- Shire Human Genetic Therapies INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 96
1. Patient must have completed the double-blind phase of Study TKT024, defined as completing the week 53 final evaluations of the study.
2. Patient, patient's parent(s), or legally authorized representative must have voluntarily signed an Institutional Review Board (IRB)/Independant Ethics Committee (IEC)-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient, according to the local study site requirements.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Patient has received treatment with an investigational therapy other than the study drug in Study TKT024 within the past 60 days.
2. 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.
3. Patient has experienced an adverse reaction to study drug in Study TKT024, which contraindicates further treatment with idursulfase.
4. Patient with known hypersensitivity to any of the components of idursulfase.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method