An Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3705 in Participants Previously Enrolled in Other Clinical Studies of mRNA-3705
Methylmalonic AcidemiaThe primary objective of this study is to evaluate the long-term safety of mRNA-3705 administered to participants with isolated methylmalonic acidemia (MMA) due to methylmalonyl-coenzyme A mutase (MUT) deficiency who have previously participated in other clinical studies of mRNA-3705.
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Participation Requirements
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Sex:
ALL -
Eligible Ages:
1 and up
Participation Criteria
Inclusion Criteria:
* Completed the assigned dose regimen treatment time period in other clinical studies of mRNA-3705 or is eligible for early transition to this study because they missed more than 3 consecutive doses of study drug due to coronavirus disease 2019 (COVID-19) vaccination during the mRNA-3705-P101 study.
* Completed the End of treatment (EOT) Visit in Study mRNA-3705-P101 within 10 days of first dose of mRNA-3705 in the current study.
Exclusion Criteria:
* Not expected to receive clinical benefit from continued mRNA-3705 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.
NOTE: Other inclusion and exclusion criteria may apply.
Study Location
Stollery Children's Hospital University of Alberta
Stollery Children's Hospital University of AlbertaEdmonton, Alberta
Canada
Contact Study Team
Hospital For Sick Children
Hospital For Sick ChildrenToronto, Ontario
Canada
Contact Study Team
- Study Sponsored By
- ModernaTX, Inc.
- Participants Required
- More Information
- Study ID:
NCT05295433