A Phase 1/2 interventional study of mRNA-3927 in Propionic Acidemia, sponsored by ModernaTX, Inc.. Recruiting at 22 sites in 8 countries. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2026-03-23.
Sponsored by ModernaTX, Inc. (part of Moderna, Inc.) · Phase 1/2, Interventional, and Treatment
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).
The study will assess long-term safety of mRNA-3927. Participants with PA who were previously enrolled and completed the end-of-treatment (EOT)/early termination (ET) visit of the mRNA-3927-P101 study will have the option to enroll into this extension study provided all eligibility criteria have been met.
The study will include 2 periods: 1) Treatment Period and 2) Follow-up Period (90 days after the EOT visit). All participants will enter the study receiving mRNA-3927 at the same dose and at the same dosing interval last received in the mRNA-3927-P101 study.
23 studies on the registry are indexed under Propionic Acidemia; 8 are open to participants now.
This study's planned enrollment of 50 is above the median of 30 across 12 interventional studies indexed under Propionic Acidemia.
Browse Propionic Acidemia studies →ModernaTX, Inc. is the lead sponsor of 119 studies on the registry; 18 are open to participants now.
Of its 64 completed or terminated interventional studies of FDA-regulated products, 35 (55%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Participants will receive the applicable dose identified during Study mRNA-3927-P101 (NCT04159103) on Day 1. The dose can be adjusted based on Sponsor recommendation.
Biological: mRNA-3927
mRNA-3927 dispersion for IV infusion
Number of Participants with Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation
Time frame: Baseline through End of Study Visit (up to 8 years)
Annualized Frequency of Investigator-reported Metabolic Decompensation Events (MDEs)
Time frame: Baseline through End of Study Visit (up to 8 years)
Annualized Frequency of Investigator-reported MDE-related Hospitalizations
Time frame: Baseline through End of Study Visit (up to 8 years)
Annualized Frequency of Investigator-reported PA-related Hospitalizations
Time frame: Baseline through End of Study Visit (up to 8 years)
Annualized Frequency of Investigator-reported PA-related Urgent Healthcare Encounters
Time frame: Baseline through End of Study Visit (up to 8 years)
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