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mRNA Therapy
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to 8 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline up to 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to 8 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Secondary outcome measures
Change From Baseline in Pediatric Quality-of-Life Inventory (PedsQL)
Change From Baseline in Plasma 2-Methylcitrate (2-MC) Levels
Change From Baseline in Plasma 3-Hydroxypropionic Acid (3-HP) Levels
+7 moreTrial 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.
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Who is running the clinical trial?
ModernaTX, Inc.Lead Sponsor
108 Previous Clinical Trials
61,379,281 Total Patients Enrolled
3 Trials studying Propionic Acidemia
265 Patients Enrolled for Propionic Acidemia
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a liver or kidney transplant.
Research Study Groups:
This trial has the following groups:- Group 1: mRNA-3927
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the sample size of this research project?
"This medical trial requires 36 participants who meet the predetermined eligibility criteria. These individuals can access this research from either Duke University Medical Center in Durham, North carolina or Michigan in Ann Arbor, Michigan."
Answered by AI
Is this research project currently open to new participants?
"Evidently, this clinical trial is still looking for participants. Clinicaltrials.gov reflects that it was initially posted on November 9th 2021 and last modified on March 14th 2022."
Answered by AI
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