RecruitingPhase 1Phase 2NCT05130437
A Study to Assess the Long-term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study
A Phase 1/2, Global, Open-Label, Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study
Sponsor
ModernaTX, Inc.
Enrollment
50 participants
Start Date
Nov 9, 2021
Study Type
INTERVENTIONAL
Conditions
Summary
The main purpose of this study is to evaluate the long-term safety of mRNA-3927 administered to participants with propionic acidemia (PA) who have previously participated in Study mRNA-3927-P101 (NCT04159103).
Eligibility
Min Age: 1 Year
Inclusion Criteria2
- Participated in Study mRNA-3927-P101.
- Completed the EOT/ET visit in Study mRNA-3927-P101 and enroll in this study such that the first dose in this study is planned to be within 14±3 days of the last dose of mRNA-3927 in the mRNA-3927-P101 study.
Exclusion Criteria3
- Not expected to receive clinical benefit from continued mRNA-3927 administration, in the opinion of the Investigator.
- Any clinical or laboratory abnormality or medical condition that, at the discretion of the Investigator, may put the individual at increased risk by participating in this study.
- History of liver and/or kidney transplant.
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Interventions
BIOLOGICALmRNA-3927
mRNA-3927 dispersion for IV infusion
Locations(22)
View Full Details on ClinicalTrials.gov
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NCT05130437
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