mRNA-3927 for Propionic Acidemia

Phase 1 & 2

Recruiting

Research Sponsored by ModernaTX, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must not have

History of liver and/or kidney transplant.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will test the long-term safety of a medication for propionic acidemia, a rare metabolic disorder.

Who is the study for?

This trial is for individuals with propionic acidemia who were previously in the mRNA-3927-P101 study. They must have completed that study's end-of-treatment visit within 10 days of starting this one. People can't join if they've had a liver or kidney transplant, aren't expected to benefit from more treatment, or have health issues that make it risky.

What is being tested?

The trial is testing the long-term safety and effectiveness of a drug called mRNA-3927 in patients with propionic acidemia who took part in an earlier phase of research. It continues where the previous study left off.

What are the potential side effects?

Since this is an extension study for mRNA-3927, side effects are monitored over a longer period but may include reactions related to immune response, potential organ stress, and other unforeseen issues as observed during ongoing surveillance.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a liver or kidney transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: mRNA-3927Experimental Treatment1 Intervention

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.

0 / 1Eligibility criteria met