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NCT01488097 · ClinicalTrials.gov registry record · Phase 2

Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of SBC-102 (Sebelipase Alfa) in Adult Subjects With Lysosomal Acid Lipase Deficiency

A Phase 2 study, sponsored by Alexion Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
8
Enrollment target

NCT01488097 is a Phase 2 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 8 participants.

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The verdict

NCT01488097, a Phase 2 study, has completed, sponsored by Alexion Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
8 participants
Enrollment target

Study 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.

Interventions

  • DRUG sebelipase alfa

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2011-12-12
Est. Completion 2017-06-21
Phase Phase 2

Sponsor

Alexion Pharmaceuticals

162 total trials

What the Registry Record Tells You About NCT01488097

The ClinicalTrials.gov registry entry for NCT01488097 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 8 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 0 conditions, and to 1 intervention - of which sebelipase alfa is the first listed.

NCT01488097 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01488097 about?

NCT01488097 is a clinical study titled "Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of SBC-102 (Sebelipase Alfa) in Adult Subjects With Lysosomal Acid Lipase Deficiency". 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.

What is the current status of trial NCT01488097?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2011-12-12. Estimated completion is 2017-06-21.

What interventions are being tested in trial NCT01488097?

The interventions under investigation include: sebelipase alfa (DRUG).

Who is sponsoring clinical trial NCT01488097?

This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.