A Study to Assess the Long-term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age1+
SponsorModernaTX, Inc.

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • mRNA-3927

Treatment groups

50 Participants
are divided into 1 treatment group

Locations

22
Canada
Hospital For Sick ChildrenM5G 1X8, TorontoOntario, Canada
France
AP-HM- Hôpital de La Timone13005, Marseille France
Hôpital Necker - Enfants Malades75019, Paris France
Japan
Fujita Health University Hospital470-1192, Toyoake-shiAkita, Japan

Sponsors and collaborators

ModernaTX, Inc.

Lead sponsor