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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 Acidemia

The 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

  • 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 Children
Toronto, Ontario
Canada

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Stollery Children's Hospital University of Alberta
Stollery Children's Hospital University of Alberta
Edmonton, Alberta
Canada

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Primary Contact

Cheri Copithorne

[email protected]
Étude parrainée par
ModernaTX, Inc.
Participants recherchés
Plus d'informations
ID de l'étude: NCT05295433