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NCT01757184 · ClinicalTrials.gov registry record · Phase 3
Acid Lipase Replacement Investigating Safety and Efficacy (ARISE) in Participants With Lysosomal Acid Lipase Deficiency
A Phase 3 study of Lysosomal Acid Lipase Deficiency, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 66
- Enrollment target
- 20
- Study locations
NCT01757184 is a Phase 3 study of Lysosomal Acid Lipase Deficiency that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 66 participants. The trial reports 20 study locations across 9 states.
The verdict
NCT01757184, a Phase 3 study of Lysosomal Acid Lipase Deficiency, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 66 participants
- Enrollment target
- 20
- Study locations
Study Summary
This Phase 3 study evaluated the efficacy and safety of 1 milligram/kilogram (mg/kg) intravenous (IV) infusions of SBC-102 (sebelipase alfa) administered every other week (qow) in participants with late onset lysosomal acid lipase deficiency (LAL-D) (cholesteryl ester storage disease \[CESD\]). Late-onset LAL-D is an underappreciated cause of cirrhosis, liver failure and dyslipidemia. There is currently no standard treatment for LAL-D other than supportive care. Enzyme replacement therapy may be a potential new treatment option for LAL-D participants.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sebelipase Alfa
Study Locations (20)
Other
- - Córdoba
- - Brisbane
- - New Lambton
- - Parkville
- - Perth
- - Zagreb
- - Olomouc
- - Prague
- - Paris
New York
- - Buffalo
- - Manhasset
- - New York
California
- - Palo Alto
- - San Francisco
Arizona
- - Tucson
Delaware
- - Wilmington
Illinois
- - Chicago
Massachusetts
- - Boston
Ohio
- - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2013-01-22 |
| Est. Completion | 2018-12-11 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01757184
The ClinicalTrials.gov registry entry for NCT01757184 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alexion Pharmaceuticals, which has 162 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Lysosomal Acid Lipase Deficiency appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01757184 reports 20 study locations spanning 9 distinct geographic areas - top geographies include Other, New York, California.
Frequently Asked Questions
What is clinical trial NCT01757184 about?
NCT01757184 is a clinical study titled "Acid Lipase Replacement Investigating Safety and Efficacy (ARISE) in Participants With Lysosomal Acid Lipase Deficiency". This Phase 3 study evaluated the efficacy and safety of 1 milligram/kilogram (mg/kg) intravenous (IV) infusions of SBC-102 (sebelipase alfa) administered every other week (qow) in participants with late onset lysosomal acid lipase deficiency (LAL-D) (cholesteryl ester storage disease \[CESD\]). Lat...
What is the current status of trial NCT01757184?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 66 participants. The study started on 2013-01-22. Estimated completion is 2018-12-11.
What conditions does trial NCT01757184 study?
This clinical trial studies the following conditions: Lysosomal Acid Lipase Deficiency.
What interventions are being tested in trial NCT01757184?
The interventions under investigation include: Placebo (DRUG), Sebelipase Alfa (DRUG).
Who is sponsoring clinical trial NCT01757184?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01757184 being conducted?
This trial has 20 study locations across Arizona, California, Delaware, Illinois, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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