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Clinical Trials/EUCTR2021-006781-21-BE
EUCTR2021-006781-21-BE
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 enrollmentJuly 28, 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
July 28, 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\. Participated in an OAV101 clinical trial.
  • •2\. Written informed consent must be obtained before any assessment is
  • •3\. Patient/Parent/legal guardian willing and able to 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

Exclusion Criteria

  • •There are no specific exclusion criteria for this study.

Outcomes

Primary Outcomes

Not specified

Similar Trials

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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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