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
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
50 participants
INTERVENTIONAL
2021-11-09
2031-12-04
Brief Summary
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Detailed Description
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The study will include 2 periods: 1) Treatment Period and 2) Follow-up Period (90 days after the EOT visit). All participants will enter the study receiving mRNA-3927 at the same dose and at the same dosing interval last received in the mRNA-3927-P101 study.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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mRNA-3927
Participants will receive the applicable dose identified during Study mRNA-3927-P101 (NCT04159103) on Day 1. The dose can be adjusted based on Sponsor recommendation.
mRNA-3927
mRNA-3927 dispersion for IV infusion
Interventions
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mRNA-3927
mRNA-3927 dispersion for IV infusion
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Year
ALL
No
Sponsors
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ModernaTX, Inc.
INDUSTRY
Responsible Party
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Locations
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Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
University of Michigan Hospitals
Ann Arbor, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Duke University Medical System (Duke Health)
Durham, North Carolina, United States
The Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, United States
Texas Children's Hospital
Houston, Texas, United States
Hospital For Sick Children
Toronto, Ontario, Canada
Fujita Health University Hospital
Toyoake-shi, Akita, Japan
Willink Biochemical Genetics Unit - Manchester
Manchester, England, United Kingdom
University Hospital Birmingham NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
Birmingham, West Midlands, United Kingdom
Great Ormond Street Hospital for Children NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2022-502911-12-00
Identifier Type: OTHER
Identifier Source: secondary_id
mRNA-3927-P101-EXT
Identifier Type: -
Identifier Source: org_study_id