At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 8 enrolled
Drug / intervention
sebelipase alfadrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open Label Multicenter Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of SBC-102 in Adult Subjects With Liver Dysfunction Due to Lysosomal Acid Lipase Deficiency Who Previously Received Treatment in Study LAL-CL01
In Brief
A Phase 2 clinical trial evaluating sebelipase alfa for Cholesterol Ester Storage Disease (CESD) and 2 related conditions. Completed, enrolled 8 participants across 10 sites in 5 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCholesterol Ester Storage Disease (CESD), Lysosomal Acid Lipase Deficiency, LAL-Deficiency
CountriesCanada, Czechia, France, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartDec 2011
Primary CompletionJun 2017
TodayJul 2026
First PostedDec 8, 2011
Enrollment StartDec 12, 2011
Primary CompletionJun 21, 2017
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 14.6 years ago
Interventions
sebelipase alfadrug
Sebelipase alfa is a recombinant human lysosomal acid lipase.