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NCT03759639 · ClinicalTrials.gov registry record · Phase 2
N-Acetyl-L-Leucine for Niemann-Pick Disease, Type C (NPC)
A Phase 2 study, sponsored by IntraBio.
- Completed
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
NCT03759639 is a Phase 2 study that has completed, run by IntraBio. The registered enrollment target is 33 participants.
The verdict
NCT03759639, a Phase 2 study, has completed, sponsored by IntraBio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
Study Summary
This is a multinational, multicenter, open-label, rater-blinded prospective Phase II study which will assess the safety and efficacy of N-Acetyl-L-Leucine (IB1001) for the treatment of Niemann-Pick type C disease (NPC). There are two phases to this study: the Parent Study, and the Extension Phase. The Parent Study evaluates the safety and efficacy of N-Acetyl-L-Leucine (IB1001) for the symptomatic treatment of NPC. The Extension Phase evaluates the long-term safety and efficacy of IB1001 for the neuroprotective, disease-modifying treatment of NPC.
Interventions
- DRUG IB1001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2019-09-04 |
| Est. Completion | 2022-11-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03759639
The ClinicalTrials.gov registry entry for NCT03759639 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is IntraBio, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which IB1001 is the first listed.
NCT03759639 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03759639 about?
NCT03759639 is a clinical study titled "N-Acetyl-L-Leucine for Niemann-Pick Disease, Type C (NPC)". This is a multinational, multicenter, open-label, rater-blinded prospective Phase II study which will assess the safety and efficacy of N-Acetyl-L-Leucine (IB1001) for the treatment of Niemann-Pick type C disease (NPC). There are two phases to this study: the Parent Study, and the Extension Phase. ...
What is the current status of trial NCT03759639?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2019-09-04. Estimated completion is 2022-11-07.
What interventions are being tested in trial NCT03759639?
The interventions under investigation include: IB1001 (DRUG).
Who is sponsoring clinical trial NCT03759639?
This trial is sponsored by IntraBio, which has 6 total clinical trials registered on ClinicalTrials.gov.
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