Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01307098 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability and Pharmacokinetics of SBC-102 (Sebelipase Alfa) in Adult Participants With Lysosomal Acid Lipase Deficiency
A Phase 1 study, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01307098 is a Phase 1 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 9 participants.
The verdict
NCT01307098, a Phase 1 study, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
This was the first clinical study of SBC-102 (sebelipase alfa) for the treatment of Lysosomal Acid Lipase (LAL) Deficiency. It was an open-label dose escalation study in adult participants with liver dysfunction due to LAL Deficiency and was designed to examine 3 doses of sebelipase alfa. The targeted number for this study was 9 evaluable participants.
Interventions
- DRUG Sebelipase alfa 0.35 mg/kg
- DRUG Sebelipase alfa 1 mg/kg
- DRUG Sebelipase alfa 3 mg/kg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2011-04-25 |
| Est. Completion | 2012-01-06 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01307098
The ClinicalTrials.gov registry entry for NCT01307098 describes a study currently listed as completed, categorized as Phase 1. 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 3 interventions - of which Sebelipase alfa 0.35 mg/kg is the first listed.
NCT01307098 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01307098 about?
NCT01307098 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of SBC-102 (Sebelipase Alfa) in Adult Participants With Lysosomal Acid Lipase Deficiency". This was the first clinical study of SBC-102 (sebelipase alfa) for the treatment of Lysosomal Acid Lipase (LAL) Deficiency. It was an open-label dose escalation study in adult participants with liver dysfunction due to LAL Deficiency and was designed to examine 3 doses of sebelipase alfa. The target...
What is the current status of trial NCT01307098?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2011-04-25. Estimated completion is 2012-01-06.
What interventions are being tested in trial NCT01307098?
The interventions under investigation include: Sebelipase alfa 0.35 mg/kg (DRUG), Sebelipase alfa 1 mg/kg (DRUG), Sebelipase alfa 3 mg/kg (DRUG).
Who is sponsoring clinical trial NCT01307098?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
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.