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

NCT05130437 · tracked via the Priya Life Science UK tracker

Sponsor

ModernaTX, Inc.

Phase

Phase 1/2

Started

2021-11-09

Last updated

2026-03-23

Condition(s) studied

Propionic Acidemia

Investigational drug(s) / intervention(s)

mRNA-3927

mRNA-3927: mRNA-3927 dispersion for IV infusion

Study summary

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

Sex

ALL

Min age

1 Year

Max age

—

Healthy volunteers

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

Number of Participants with Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation — Baseline through End of Study Visit (up to 8 years)

Trial sites (22)

Facility	City	Region	Status
Ronald Reagan UCLA Medical Center	Los Angeles	California	Not Yet Recruiting
University of Stanford Medical Center	Palo Alto	California	Recruiting
University of Michigan Hospitals	Ann Arbor	Michigan	Recruiting
Icahn School of Medicine at Mount Sinai	New York	New York	Recruiting
Duke University Medical System (Duke Health)	Durham	North Carolina	Recruiting
The Children's Hospital of Philadelphia (CHOP)	Philadelphia	Pennsylvania	Recruiting
Texas Children's Hospital	Houston	Texas	Recruiting
Hospital For Sick Children	Toronto	Ontario	Recruiting
AP-HM- Hôpital de La Timone	Marseille	France	Not Yet Recruiting
Hôpital Necker - Enfants Malades	Paris	France	Not Yet Recruiting
Fujita Health University Hospital	Toyoake-shi	Akita	Recruiting
Tohoku University Hospital	Sendai	Miyagi	Recruiting
Erasmus MC -Dr. Molewaterplein 40	Rotterdam	South Holland	Not Yet Recruiting
Universitair Medisch Centrum Utrecht - PPDS	Utrecht	Netherlands	Not Yet Recruiting
King Faisal Specialist Hospital & Research Centre	Riyadh	Ar Riya	Not Yet Recruiting
King Abdullah Children's Specialist Hospital	Riyadh	Ar Riya	Not Yet Recruiting
Hospital Universitario Cruces	Barakaldo	Vizcaya	Not Yet Recruiting
Hospital Universitario 12 de Octubre	Madrid	Spain	Not Yet Recruiting
Willink Biochemical Genetics Unit - Manchester	Manchester	England	Recruiting
University Hospital Birmingham NHS Foundation Trust	Birmingham	West Midlands	Recruiting
Birmingham Women's and Children's NHS Foundation Trust	Birmingham	West Midlands	Completed
Great Ormond Street Hospital for Children NHS Foundation Trust	London	United Kingdom	Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05130437 on ClinicalTrials.gov ↗ ← All trials in the UK