A Phase 1/2, Global, Open-Label, Extension Study to Evaluate the Long-Term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study
Who is this study for? Patients with propionic acidemia
What treatments are being studied? mRNA-3927
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 1
Healthy Volunteers: f
View:
• Participated in Study mRNA-3927-P101.
• Completed the EOT Visit in Study mRNA-3927-P101 within 10 days of first dose of mRNA-3927 in current study.
Locations
United States
California
Ronald Reagan UCLA Medical Center
RECRUITING
Los Angeles
Michigan
University of Michigan Hospitals
RECRUITING
Ann Arbor
North Carolina
Duke University Medical System (Duke Health)
RECRUITING
Durham
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Pennsylvania
The Children's Hospital of Philadelphia (CHOP)
RECRUITING
Philadelphia
Texas
Texas Children's Hospital
RECRUITING
Houston
Other Locations
Canada
Hospital For Sick Children
RECRUITING
Toronto
Japan
Fujita Health University Hospital
NOT_YET_RECRUITING
Toyoake-shi
United Kingdom
Birmingham Women's and Children's NHS Foundation Trust
COMPLETED
Birmingham
University Hospital Birmingham NHS Foundation Trust
RECRUITING
Birmingham
Great Ormond Street Hospital for Children NHS Foundation Trust
RECRUITING
London
Willink Biochemical Genetics Unit - Manchester
RECRUITING
Manchester
Contact Information
Primary
Moderna WeCare Team
WeCareClinicalTrials@modernatx.com
1-866-663-3762
Time Frame
Start Date: 2021-11-09
Estimated Completion Date: 2031-12-04
Participants
Target number of participants: 36
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: ModernaTX, Inc.