Skip to main content
MedPathMedPath Home
Clinical Trials/EUCTR2019-002611-26-IT
EUCTR2019-002611-26-IT
Active, not recruiting
Phase 1

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

AVEXIS, INC.0 sites308 target enrollmentAugust 3, 2021
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsSpinal Muscular AtrophyMedDRA version: 20.1Level: PTClassification code 10041582Term: Spinal muscular atrophySystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic 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
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 3, 2021
End Date
TBD
Last Updated
4 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:
  • •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

Similar Trials

Active, not recruiting
Phase 1
/ASpinal 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]
CTIS2024-513086-39-00ovartis Pharma AG131
Active, not recruiting
Phase 1
ot applicableSpinal Muscular AtrophyTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
EUCTR2019-002611-26-GBAveXis, Inc.308
Active, not recruiting
Phase 1
ot applicableSpinal Muscular AtrophyTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
EUCTR2019-002611-26-BEovartis Gene Therapies, Inc.308
Active, not recruiting
Phase 1
ot applicableSpinal Muscular AtrophyTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
EUCTR2019-002611-26-FRAveXis, Inc.308
Active, not recruiting
Phase 1
ot applicable
EUCTR2019-002611-26-ESAveXis, Inc.308