Status:
TERMINATED
Open-Label Extension Study of Recombinant Human Arylsulfatase A (HGT-1111) in Late Infantile MLD
Lead Sponsor:
Shire
Conditions:
Late Infantile Metachromatic Leukodystrophy
Eligibility:
All Genders
3-6 years
Phase:
PHASE2
Brief Summary
This is a multi-center, open-label, extension study of patients with late infantile MLD who have previously completed clinical study HGT-MLD-048 (NCT00633139), defined as the completion of all Week 52...
Detailed Description
The primary objective of this study is to provide ongoing treatment of HGT-1111 to patients who have completed study HGT-MLD-048 (previously study rhASA-03 - NCT00633139) until HGT-1111 is commerciall...
Eligibility Criteria
Inclusion
- 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)
- Completion of study HGT-MLD-048 (NCT00633139)
- The subject and his/her guardian(s) must have the ability to comply with the 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
Key Trial Info
Start Date :
February 20 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 22 2010
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00681811
Start Date
February 20 2008
End Date
October 22 2010
Last Update
June 8 2021
Active Locations (1)
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1
Rigshospitalet
Copenhagen, Denmark, 2100