An observational study in Propionic Acidemia, sponsored by ModernaTX, Inc.. Recruiting at 29 sites in 9 countries. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by ModernaTX, Inc. (part of Moderna, Inc.) · Observational
This is a non-interventional, observational, global, multicenter, study describing participant characteristics, clinical outcomes, and event rates in participants with propionic acidemia (PA).
Data will be abstracted through medical record review ensuring inclusion only of data from participants meeting all the inclusion criteria and none of the censoring criteria. Data will be collected retrospectively from study sites, including medical clinics, hospitals and academic medical centers.
23 studies on the registry are indexed under Propionic Acidemia; 8 are open to participants now.
This study's planned enrollment of 60 is below the median of 78 across 10 observational 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.
Individuals of a minimum age of 2 years with confirmed diagnosis of PA.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants' medical records are eligible for abstraction only if all of the following criteria apply:
Censoring Criteria:
Participants medical records meeting the following censoring criterion will not be abstracted:
Exclusion Criteria:
Participant's medical records will not be eligible for abstraction if the participant meets the following exclusion criteria:
- Participation (prior or ongoing) in clinical study mRNA-3927-P101 (NCT04159103) or mRNA-3927-P101-EXT (NCT05130437).
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with PA who meet all eligibility criteria for medical record abstraction.
Number of Annualized Clinical Event Committee (CEC)-adjudicated Metabolic Decompensation Events (MDEs)
Time frame: Up to 10 years
Number of CEC-adjudicated MDEs as Assessed by a Pre-Specified Severity Rating Scale
Time frame: Up to 10 years
Number of Annualized CEC-adjudicated PA-related Hospitalizations
Time frame: Up to 10 years
Number of Annualized CEC-adjudicated MDE-related Hospitalizations
Time frame: Up to 10 years
Number of Annualized CEC-adjudicated PA-related Urgent Healthcare Visits
Time frame: Up to 10 years
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Started Jun 2023 (actual). Primary completion is estimated for Sep 2026, 39 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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