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Safety and Efficacy Study of Sebelipase Alfa in Participants With Lysosomal Acid Lipase Deficiency

NCT02112994 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-12-04

Study results available
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Summary

This study evaluated the safety and efficacy of sebelipase alfa in a broad population of participants with lysosomal acid lipase deficiency (LAL-D).

Conditions

  • Lysosomal Acid Lipase Deficiency

Interventions

DRUG

Sebelipase Alfa

IV infusion of sebelipase alfa

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
8 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-24
Primary Completion
2017-12-28
Completion
2017-12-28
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Croatia
  • Denmark
  • Germany
  • Italy
  • Mexico
  • Netherlands
  • Russia
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02112994 on ClinicalTrials.gov