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NCT01371825 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency
A Phase 2 study, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
NCT01371825 is a Phase 2 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 9 participants.
The verdict
NCT01371825, a Phase 2 study, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
Study Summary
This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency. Eligible participants received once-weekly (qw) infusions of sebelipase alfa for up to 5 years.
Interventions
- DRUG Sebelipase alfa (SBC-102)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-05-04 |
| Est. Completion | 2018-01-03 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01371825
The ClinicalTrials.gov registry entry for NCT01371825 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 9 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 (SBC-102) is the first listed.
NCT01371825 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01371825 about?
NCT01371825 is a clinical study titled "Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Sebelipase Alfa in Children With Growth Failure Due to Lysosomal Acid Lipase Deficiency". This was an open-label, repeat-dose, intra-participant dose-escalation study of SBC-102 (sebelipase alfa) in children with growth failure due to lysosomal acid lipase (LAL) Deficiency. Eligible participants received once-weekly (qw) infusions of sebelipase alfa for up to 5 years.
What is the current status of trial NCT01371825?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2011-05-04. Estimated completion is 2018-01-03.
What interventions are being tested in trial NCT01371825?
The interventions under investigation include: Sebelipase alfa (SBC-102) (DRUG).
Who is sponsoring clinical trial NCT01371825?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
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