Status:
COMPLETED
Long-term Metazym Treatment of Patients With Late Infantile Metachromatic Leukodystrophy (MLD)
Lead Sponsor:
Shire
Conditions:
Late Infantile Metachromatic Leukodystrophy
Eligibility:
All Genders
1-5 years
Phase:
PHASE1
PHASE2
Brief Summary
This is a single center, open-label study of patients with late infantile MLD. All patients were previous treated 26 weeks in the phase I trial (EudraCT number: 2006-005341-11, NCT00418561). All patie...
Eligibility Criteria
Inclusion
- The patients from the Phase I trial must meet the following criteria to be enrolled in the study.
- Subject's legally authorized guardian(s) must provide signed, informed consent prior to performing any study-related activities (trial-related activities are any procedures that would not have been performed during normal management of the subject)
- The subject and his/her guardian(s) must have the ability to comply with the clinical protocol
Exclusion
- Spasticity so severe to inhibit transportation
- Presence of known clinically significant cardiovascular, hepatic, pulmonary or renal disease or other medical condition that, in the opinion of the Investigator, would preclude participation in the trial
- Any other medical condition or serious intercurrent illness, or extenuating circumstance that, in the opinion of the Investigator, would preclude participation in the trial
- Use of any investigational product other than rhASA within 30 days prior to study enrolment or currently enrolled in another study which involves clinical investigations
Key Trial Info
Start Date :
January 22 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00633139
Start Date
January 22 2007
End Date
November 25 2008
Last Update
June 14 2021
Active Locations (1)
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1
PhaseOneTrials A/S
Hvidovre, Denmark, 2650