Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of SBC-102 (Sebelipase Alfa) in Adult Subjects With Lysosomal Acid Lipase Deficiency
Study Identifier:
LAL-CL04
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Available Documents
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: sebelipase alfa
Date
Dec 2011 - Jun 2017
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Participant received all 4 scheduled doses of sebelipase alfa in Study LAL-CL01 with no life-threatening or unmanageable study drug toxicity.
Exclusion Criteria
- 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
Sex
Female & Male
Age
18+ years
Study Details
Medical Condition
- Unmapped
Study Drug
- Drug: sebelipase alfa
Date
Dec 2011 - Jun 2017
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Participant received all 4 scheduled doses of sebelipase alfa in Study LAL-CL01 with no life-threatening or unmanageable study drug toxicity.
Exclusion Criteria
- 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
Protocol 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 dysfunction due to lysosomal acid lipase (LAL) deficiency.
Trial Locations
Location
Status
Location
Eureka, California, United States, 95501-320
Status
N/A
Location
Sacramento, California, United States, 95817
Status
N/A
Location
San Francisco, California, United States, 94143
Status
N/A
Location
Minneapolis, Minnesota, United States, 55455
Status
N/A
Location
New York, New York, United States, 10029
Status
N/A
Location
Greater Sudbury, Ontario, Canada
Status
N/A
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