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Clinical Trials/EUCTR2021-006781-21-FR
EUCTR2021-006781-21-FR
Active, not recruiting
Phase 1

ong-term follow-up of patients with spinal muscular atrophy Treated with OAV101 IT or OAV101 IV in Clinical Trials

ovartis Pharma AG0 sites260 target enrollmentAugust 18, 2022
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ConditionsSpinal Muscular AtrophyMedDRA version: 20.1Level: PTClassification code 10041582Term: Spinal muscular atrophySystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
DrugsZolgensma 2 x 1013 vg (vector genomes)/mL solution for infusion

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Spinal Muscular Atrophy
Sponsor
ovartis Pharma AG
Enrollment
260
Status
Active, not recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 18, 2022
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Participants eligible for inclusion in this study must meet all of the following criteria:
  • •1\. Received OAV101 IT or OAV101 IV in a Phase I to IIIb clinical trial sponsored by AveXis, Novartis or Novartis Gene Therapies.
  • •2\. Patient/Parent/legal guardian willing and able to complete the informed consent process and comply with study procedures.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 260
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •Score yes” on item 4 or item 5 of the suicidal ideation section of the C\-SSRS, if this ideation occurred in the past 6 months, or yes” on any item of the suicidal behavior section, except for the Non\-Suicidal Self\-Injurious Behavior” (item also included in the suicidal behavior section) if this behavior occurred in the past 2 years.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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Phase 1
ong-term follow-up of patients with spinal muscular atrophy Treated with OAV101 in Clinical TrialsSpinal Muscular AtrophyMedDRA version: 20.1Level: PTClassification code 10041582Term: Spinal muscular atrophySystem Organ Class: 10010331 - Congenital, familial and genetic disordersTherapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
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