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NCT04851873 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA)
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 24
- Enrollment target
NCT04851873 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 24 participants.
The verdict
NCT04851873, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 24 participants
- Enrollment target
Study Summary
To evaluate the safety, tolerability and efficacy of intravenous administration of OAV101 (AVXS-101) in patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene weighing ≥ 8.5 kg and ≤ 21 kg, over a 12 month period.
Interventions
- GENETIC OAV101
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2021-09-08 |
| Est. Completion | 2023-06-13 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04851873
The ClinicalTrials.gov registry entry for NCT04851873 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which OAV101 is the first listed.
NCT04851873 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04851873 about?
NCT04851873 is a clinical study titled "Safety and Efficacy of Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA)". To evaluate the safety, tolerability and efficacy of intravenous administration of OAV101 (AVXS-101) in patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene weighing ≥ 8.5 kg and ≤ 21 kg, over a 12 month period.
What is the current status of trial NCT04851873?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 24 participants. The study started on 2021-09-08. Estimated completion is 2023-06-13.
What interventions are being tested in trial NCT04851873?
The interventions under investigation include: OAV101 (GENETIC).
Who is sponsoring clinical trial NCT04851873?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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