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Clinical Trials in Japan / NCT05130437
Recruiting Phase 1/2

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 Japan 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
No
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)

FacilityCityRegionStatus
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

More ModernaTX, Inc. trials in Japan

Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors Active, not recruiting
A Study to Investigate the Safety and Efficacy of mRNA-1403 in Participants ≥18 Years of Age for the Prevention of Acute Gastroenteritis Active, not recruiting
A Retrospective Study to Characterize Participants With Propionic Acidemia Recruiting
Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia Recruiting

Other trials for the same condition

A Retrospective Study to Characterize Participants With Propionic Acidemia Recruiting
Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia 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 Japan