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Clinical Trials/EUCTR2019-002611-26-GB
EUCTR2019-002611-26-GB
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 enrollmentDecember 31, 2019
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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
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 31, 2019
End Date
TBD
Last Updated
5 years ago
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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