NCT05130437 A Study to Assess the Long-term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study
| NCT ID | NCT05130437 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | ModernaTX, Inc. |
| Condition | Propionic Acidemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-11-09 |
| Primary Completion | 2029-12-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 50 participants in total. It began in 2021-11-09 with a primary completion date of 2029-12-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05130437 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, studying Propionic Acidemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05130437 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05130437 currently recruiting?
Yes, NCT05130437 is actively recruiting participants. Contact the research team at WeCareClinicalTrials@modernatx.com for enrollment information.
Where is the NCT05130437 trial being conducted?
This trial is being conducted at Los Angeles, United States, Palo Alto, United States, Ann Arbor, United States, New York, United States and 11 additional locations.
Who is sponsoring the NCT05130437 clinical trial?
NCT05130437 is sponsored by ModernaTX, Inc.. The trial plans to enroll 50 participants.