Status:
RECRUITING
An Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3705 in Participants Previously Enrolled in Other Clinical Studies of mRNA-3705
Lead Sponsor:
ModernaTX, Inc.
Conditions:
Methylmalonic Acidemia
Eligibility:
All Genders
1+ years
Phase:
PHASE1
PHASE2
Brief Summary
The primary objective of this study is to evaluate the long-term safety and clinical activity of mRNA-3705 administered to participants with isolated methylmalonic acidemia (MMA) due to methylmalonyl-...
Detailed Description
Participants with isolated MMA due to MUT deficiency who were previously enrolled in other clinical studies of mRNA-3705 will have the option to enroll into this extension study provided all eligibili...
Eligibility Criteria
Inclusion
- Completed the assigned dose regimen treatment time period in other clinical studies of mRNA-3705 or is eligible for early transition to this study because they missed more than 3 consecutive doses of study drug due to coronavirus disease 2019 (COVID-19) vaccination during Study mRNA-3705-P101 Part 1.
- Completed the End of treatment (EOT) Visit (or End of Study Visit in the case of unscheduled dosing) in Study mRNA-3705-P101 within 10 days of their first dose of mRNA-3705 in this extension study.
Exclusion
- Not expected to receive clinical benefit from continued mRNA-3705 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.
- NOTE: Other inclusion and exclusion criteria may apply.
Key Trial Info
Start Date :
March 8 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 2 2034
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT05295433
Start Date
March 8 2022
End Date
April 2 2034
Last Update
December 23 2025
Active Locations (12)
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1
UCLA Medical Center
Los Angeles, California, United States, 90095
2
Lucile Packard Children's Hospital at Stanford
Palo Alto, California, United States, 94304
3
Altman Clinical and Translational Research Institution
San Diego, California, United States, 92037
4
Stollery Children's Hospital University of Alberta
Edmonton, Alberta, Canada, T6G 2R7