Status:
COMPLETED
Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of SBC-102 (Sebelipase Alfa) in Adult Subjects With Lysosomal Acid Lipase Deficiency
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Cholesterol Ester Storage Disease (CESD)
Lysosomal Acid Lipase Deficiency
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This was an extension study to Study LAL-CL01 (NCT01307098). The primary objective of the study was to evaluate the long-term safety and tolerability of sebelipase alfa in participants with liver dysf...
Detailed Description
Participants who successfully received all 4 doses of sebelipase alfa in Study LAL-CL01 and opted to continue treatment in the extension study underwent screening assessments to determine study eligib...
Eligibility Criteria
Inclusion
- Participant received all 4 scheduled doses of sebelipase alfa in Study LAL-CL01 with no life-threatening or unmanageable study drug toxicity.
Exclusion
- Clinically significant concurrent disease, serious inter-current illness, concomitant medications or other extenuating circumstances
- Clinically significant abnormal values on laboratory screening tests, other than LFTs or lipid panel tests
Key Trial Info
Start Date :
December 12 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 21 2017
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01488097
Start Date
December 12 2011
End Date
June 21 2017
Last Update
July 20 2018
Active Locations (10)
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1
Eureka, California, United States, 95501-320
2
Sacramento, California, United States, 95817
3
San Francisco, California, United States, 94143
4
Minneapolis, Minnesota, United States, 55455