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Clinical Trials/EUCTR2019-002611-26-FR
EUCTR2019-002611-26-FR
Active, not recruiting
Phase 1

A Long-term Follow-up Study of Patients in the Clinical Trials forSpinal Muscular Atrophy Receiving AVXS-101 - not applicable

AveXis, Inc.0 sites308 target enrollmentMarch 10, 2020
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ConditionsSpinal Muscular AtrophyTherapeutic area: Diseases [C] - Nervous System Diseases [C10]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Spinal Muscular Atrophy
Sponsor
AveXis, Inc.
Enrollment
308
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 10, 2020
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AveXis, Inc.

Eligibility Criteria

Inclusion Criteria

  • •\> Patients with SMA (with 1, 2 or 3copies of SMN2\) who received AVXS\-101 gene replacement therapy in an AveXis clinical study
  • •\> Patient/parent/legal guardian willing and able to complete the informed consent process and comply with study procedures and visit schedule
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 308
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 64
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •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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