Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
Study Identifier:
LAL-CL03
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: Sebelipase alfa (SBC-102)
Date
May 2011 - Jan 2018
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A - 24 Months
Requirements Information
Sex
Female & Male
Age
N/A - 24 Months
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: Sebelipase alfa (SBC-102)
Date
May 2011 - Jan 2018
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A - 24 Months years
Requirements Information
Protocol Summary
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency. Eligible participants received once-weekly (qw) infusions of sebelipase alfa for up to 5 years.
Trial Locations
Location
Status
Location
Irvine, California, United States, 92697
Status
N/A
Location
Cairo, Egypt, 11771
Status
N/A
Location
Grenoble, France, 38700
Status
N/A
Location
Paris, France, 75015
Status
N/A
Location
Dublin, Ireland, 1
Status
N/A
Location
London, United Kingdom, SE1 7EH
Status
N/A