Actively Recruiting
A Phase 1/2, Global, Open-Label Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study
Led by ModernaTX, Inc. · Updated on 2026-03-23
50
Participants Needed
22
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the long-term safety of mRNA-3927 in people with propionic acidemia (PA) who previously took part in the mRNA-3927-P101 study. It is a phase 1/2, open-label extension study focusing on monitoring safety and clinical activity over an extended period. Participants will continue receiving mRNA-3927 at the same dose and schedule they had in the earlier study, with dose adjustments possible based on the sponsor's recommendation. The study includes two main periods: a treatment period where participants receive the study drug, followed by a 90-day follow-up period after the end of treatment. During the study, researchers will monitor participants for adverse events, serious side effects, and any events leading to stopping treatment. They will also track metabolic decompensation events and hospitalizations related to PA over up to eight years. Participants will have regular assessments to evaluate these outcomes and ensure ongoing safety throughout the study duration.
CONDITIONS
Brief Title
A Study to Assess the Long-term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participated in Study mRNA-3927-P101
- Completed the end-of-treatment or early termination visit in Study mRNA-3927-P101
- Planned first dose in this study within 14 ±3 days of last dose in Study mRNA-3927-P101
You will not qualify if you...
- Not expected to benefit from continued mRNA-3927 treatment, according to the Investigator
- Any medical or laboratory condition that may increase risk as judged by the Investigator
- History of liver and/or kidney transplant
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 years
Participants receive mRNA-3927 at the dose and interval last received in the previous study. Dose adjustments may be made based on Sponsor recommendations.
Visits scheduled according to dosing and assessment needs during treatment
Duration - 90 days
Participants are monitored for safety and clinical activity for 90 days after completing treatment.
1 to 2 visits during follow-up
Trial Site Locations
Total: 22 locations
1
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Not Yet Recruiting
2
University of Stanford Medical Center
Palo Alto, California, United States, 94304-1503
Actively Recruiting
3
University of Michigan Hospitals
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
5
Duke University Medical System (Duke Health)
Durham, North Carolina, United States, 27710
Actively Recruiting
6
The Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
7
Texas Children's Hospital
Houston, Texas, United States, 77030
Actively Recruiting
8
Hospital For Sick Children
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
9
AP-HM- Hôpital de La Timone
Marseille, France, 13005
Not Yet Recruiting
10
Hôpital Necker - Enfants Malades
Paris, France, 75019
Not Yet Recruiting
11
Fujita Health University Hospital
Toyoake-shi, Akita, Japan, 470-1192
Actively Recruiting
12
Tohoku University Hospital
Sendai, Miyagi, Japan, 980-8574
Actively Recruiting
13
Erasmus MC -Dr. Molewaterplein 40
Rotterdam, South Holland, Netherlands, 3015 GD
Not Yet Recruiting
14
Universitair Medisch Centrum Utrecht - PPDS
Utrecht, Netherlands, 3584 CX
Not Yet Recruiting
15
King Faisal Specialist Hospital & Research Centre
Riyadh, Ar Riya, Saudi Arabia, 11211
Not Yet Recruiting
16
King Abdullah Children's Specialist Hospital
Riyadh, Ar Riya, Saudi Arabia, 14611
Not Yet Recruiting
17
Hospital Universitario Cruces
Barakaldo, Vizcaya, Spain, 48903
Not Yet Recruiting
18
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Not Yet Recruiting
19
Willink Biochemical Genetics Unit - Manchester
Manchester, England, United Kingdom, M13 9WL
Actively Recruiting
20
University Hospital Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B15 2TH
Actively Recruiting
21
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, West Midlands, United Kingdom, B4 6NH
Completed
22
Great Ormond Street Hospital for Children NHS Foundation Trust
London, United Kingdom, WC1N 3JH
Actively Recruiting
Research Team
M
Moderna WeCare Team
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here