Status:
RECRUITING
A Study to Assess the Long-term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study
Lead Sponsor:
ModernaTX, Inc.
Conditions:
Propionic Acidemia
Eligibility:
All Genders
1+ years
Phase:
PHASE1
PHASE2
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 (NCT0...
Detailed Description
The study will assess long-term safety of mRNA-3927. Participants with PA who were previously enrolled and completed the end-of-treatment (EOT)/early termination (ET) visit of the mRNA-3927-P101 study...
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.
Key Trial Info
Start Date :
November 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 4 2031
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05130437
Start Date
November 9 2021
End Date
December 4 2031
Last Update
March 23 2026
Active Locations (22)
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1
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
2
University of Stanford Medical Center
Palo Alto, California, United States, 94304-1503
3
University of Michigan Hospitals
Ann Arbor, Michigan, United States, 48109
4
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029