A multi-center open label extension study of HGT-1111 (Recombinant Human Arylsulfatase A or rhASA) treatment in patients with Late Infantile Metachromatic Leukodystrophy (MLD)
- Conditions
- Metachromatic Leukodystrophy (MLD) in late infantile patientsMedDRA version: 9.1Level: LLTClassification code 10024381Term: Leukodystrophy
- Registration Number
- EUCTR2008-000084-41-BE
- Lead Sponsor
- Shire Human Genetic Therapies Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 11
1. The patient's legally authorized guardian(s) must provide signed informed consent prior to the performance of any study-related activities. (Study-related activities are any procedures that would not have been performed during normal management of the subject).
2. Completion of study HGT-MLD-048
3. The patient and his/her guardian(s) must have the ability to comply with the clinical protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
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. Spasticity so severe that it inhibiits the patient from being transported to the treatment site.
2. Presence of known clinically significant cardiovascular, hepatic, pulmonary or renal disease or any other medical condition that, in the opinion of the investigator, would preclude participatioin in the trial.
3. Any other medical condition or serious intercurrent illness or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial.
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