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NCT05335876 · ClinicalTrials.gov registry record · Phase 3
Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials
A Phase 3 study of Spinal Muscular Atrophy (SMA), sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 175
- Enrollment target
- 20
- Study locations
NCT05335876: Recruiting Phase 3 study of Spinal Muscular Atrophy (SMA), sponsored by Novartis Pharmaceuticals.
NCT05335876 is a Phase 3 study of Spinal Muscular Atrophy (SMA) that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 175 participants, below the 248-participant average among 5 other Spinal Muscular Atrophy (SMA) trials with a reported enrollment target (29% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05335876, a Phase 3 study of Spinal Muscular Atrophy (SMA), is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 175 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a global, prospective, multi-center study that is designed to assess the long-term safety and efficacy of OAV101 in patients who participated in an OAV101 clinical trial. The assessments of safety and efficacy in Study COAV101A12308 will continue for 5 years after enrollment in this study.
Primary Outcome
An SAE is defined as any adverse event \[appearance of (or worsening of any pre-existing)\] undesirable sign(s), symptom(s), or medical conditions(s) which meets any one of the following criteria: * fatal * life-threatening * results in persistent or significant disability/incapacity * constitutes a congenital anomaly/birth defect, fetal death or congenital abnormality or birth defect * requires in-patient hospitalization or prolongation of existing hospitalization, unless hospitalization is fo
Conditions Studied
Interventions
- BIOLOGICAL onasemnogene abeparvovec
Study Locations (20)
Other
- Novartis Investigative Site - Leuven
- Novartis Investigative Site - Beijing
- Novartis Investigative Site - Beijing
- Novartis Investigative Site - Beijing
- Novartis Investigative Site - Copenhagen
- Novartis Investigative Site - Bron
- Novartis Investigative Site - Garches
- Novartis Investigative Site - Strasbourg
- Novartis Investigative Site - Toulouse
Virginia
- Child Hosp Of The Kings Daughters - Norfolk
New South Wales
- Novartis Investigative Site - Sydney
Paraná
- Novartis Investigative Site - Curitiba
São Paulo
- Novartis Investigative Site - São Paulo
Quebec
- Novartis Investigative Site - Montreal
Chongqing Municipality
- Novartis Investigative Site - Chongqing
Guangdong
- Novartis Investigative Site - Guangzhou
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 175 participants |
| Start Date | 2022-12-19 |
| Est. Completion | 2031-02-27 |
| Phase | Phase 3 |
What NCT05335876 shows while recruiting
NCT05335876 is an interventional study that assigns participants to a tested intervention. The registered 175 participants enrollment target is mid-sized for trials with a published cap, below the 248-participant average among 5 other Spinal Muscular Atrophy (SMA) trials with a reported enrollment target (29% lower).
The record links to 1 condition, with Spinal Muscular Atrophy (SMA) appearing as the primary indexed condition, and to 1 intervention - of which onasemnogene abeparvovec is the first listed.
NCT05335876 names 20 study sites across 12 states, led by Other, Virginia, New South Wales.
Frequently Asked Questions
What is clinical trial NCT05335876 about?
NCT05335876 is a clinical study titled "Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials". This is a global, prospective, multi-center study that is designed to assess the long-term safety and efficacy of OAV101 in patients who participated in an OAV101 clinical trial. The assessments of safety and efficacy in Study COAV101A12308 will continue for 5 years after enrollment in this study.
What is the current status of trial NCT05335876?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 175 participants. The study started on 2022-12-19. Estimated completion is 2031-02-27.
What conditions does trial NCT05335876 study?
This clinical trial studies the following conditions: Spinal Muscular Atrophy (SMA).
What interventions are being tested in trial NCT05335876?
The interventions under investigation include: onasemnogene abeparvovec (BIOLOGICAL).
Who is sponsoring clinical trial NCT05335876?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05335876 being conducted?
This trial has 20 study locations across Virginia, New South Wales, Paraná, São Paulo, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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