Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

Long-term Follow-up of Patients With Spinal Muscular Atrophy Treated With OAV101 in Clinical Trials

NCT05335876 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 175 participants
Start Date 2022-12-19
Est. Completion 2031-02-27
Phase Phase 3

Sponsor

Novartis Pharmaceuticals

792 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05335876

The ClinicalTrials.gov registry entry for NCT05335876 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 175 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05335876 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Other, Virginia, New South Wales. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05335876?

The interventions under investigation include: onasemnogene abeparvovec (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05335876?

This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial