A Study to Assess the Long-term Safety and Clinical Activity of mRNA-3927 in Participants Previously Enrolled in the mRNA-3927-P101 Study

Part of paid clinical trials in Los Angeles, California.

Sponsor
ModernaTX, Inc.
Study ID
NCT05130437
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Propionic Acidemia

Eligibility Criteria

Sex
ALL
Age
1 Year - N/A
Healthy Volunteers
Not accepted

Interventions

  • mRNA-3927 — BIOLOGICAL
    mRNA-3927 dispersion for IV infusion

Study Details

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).

Key Dates

Start date
Nov 9, 2021
Status verified
Mar 2026
Primary completion
Dec 4, 2029
Completion
Dec 4, 2031

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Number of Participants with Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation [ Time Frame: Baseline through End of Study Visit (up to 8 years) ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90095-
University of Stanford Medical CenterPalo AltoCalifornia94304-1503-
University of Michigan HospitalsAnn ArborMichigan48109-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
Duke University Medical System (Duke Health)DurhamNorth Carolina27710-
The Children's Hospital of Philadelphia (CHOP)PhiladelphiaPennsylvania19104-
Texas Children's HospitalHoustonTexas77030-

Find similar trials in Los Angeles, CA

By research site
Ronald Reagan UCLA Medical Center· Los Angeles, CAUniversity of Stanford Medical Center· Palo Alto, CAUniversity of Michigan Hospitals· Ann Arbor, MIIcahn School of Medicine at Mount Sinai· New York, NYDuke University Medical System (Duke Health)· Durham, NCThe Children's Hospital of Philadelphia (CHOP)· Philadelphia, PA

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