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Clinical Trials/CTIS2024-513086-39-00
CTIS2024-513086-39-00
Active, not recruiting
Phase 1

A Long-term Follow-up Study of Patients in the Clinical Trials for Spinal Muscular Atrophy Receiving AVXS-101 - AVXS-101-LT-002

ovartis Pharma AG0 sites131 target enrollmentMay 24, 2024
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ConditionsSpinal Muscular AtrophyMedDRA version: 20.0Level: LLTClassification code: 10079413Term: Spinal muscular atrophy type I Class: 10010331MedDRA version: 20.0Level: LLTClassification code: 10079415Term: Spinal muscular atrophy type III Class: 10010331MedDRA version: 20.0Level: LLTClassification code: 10079416Term: Spinal muscular atrophy type II Class: 10010331Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Spinal Muscular Atrophy
Sponsor
ovartis Pharma AG
Enrollment
131
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 24, 2024
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Any patient with SMA who received AVXS\-101 gene replacement therapy in a Novartis Pharma AG \-sponsored clinical study, Patient/parent/legal guardian willing and able to complete the informed consent process and comply with study procedures and visit schedule

Exclusion Criteria

  • •Patient/parent/legal guardian unable or unwilling to participate in the long\-term follow\-up safety study

Outcomes

Primary Outcomes

Not specified

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