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 and clinical activity 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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Conditions de participation
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Sexe:
ALL -
Âges admissibles:
1 and up
Critères de participation
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 Study mRNA-3705-P101 Part 1.
* Completed the End of treatment (EOT) Visit (or End of Study Visit in the case of unscheduled dosing) in Study mRNA-3705-P101 within 10 days of their first dose of mRNA-3705 in this extension 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.
Lieu de l'étude
Hospital For Sick Children
Hospital For Sick ChildrenToronto, Ontario
Canada
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Stollery Children's Hospital University of Alberta
Stollery Children's Hospital University of AlbertaEdmonton, Alberta
Canada
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- Étude parrainée par
- ModernaTX, Inc.
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT05295433