Safety, Tolerability and Pharmacokinetics of SBC-102 (Sebelipase Alfa) in Adult Participants With Lysosomal Acid Lipase Deficiency
Study Identifier:
LAL-CL01
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 0.35 mg/kg
- Drug: Sebelipase alfa 1 mg/kg
- Drug: Sebelipase alfa 3 mg/kg
Date
Apr 2011 - Jan 2012
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years
Requirements Information
Sex
Female & Male
Age
18 - 65 Years
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: Sebelipase alfa 0.35 mg/kg
- Drug: Sebelipase alfa 1 mg/kg
- Drug: Sebelipase alfa 3 mg/kg
Date
Apr 2011 - Jan 2012
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 65 Years years
Requirements Information
Protocol Summary
This was the first clinical study of SBC-102 (sebelipase alfa) for the treatment of Lysosomal Acid Lipase (LAL) Deficiency. It was an open-label dose escalation study in adult participants with liver dysfunction due to LAL Deficiency and was designed to examine 3 doses of sebelipase alfa. The targeted number for this study was 9 evaluable participants.
Trial Locations
Location
Status
Location
Stanford, California, United States, 94305
Status
N/A
Location
New York, New York, United States, 10029
Status
N/A
Location
Pittsburgh, Pennsylvania, United States, 15213
Status
N/A
Location
Prague, Czech Republic, 12000
Status
N/A
Location
Paris, France, 75743
Status
N/A
Location
Cambridge, United Kingdom, CB20QQ
Status
N/A