Clinical Trials Logo
  1. Home
  2. Propionic Acidemia
  3. NCT05130437

A Long-Term Extension Study to Evaluate the Safety and Clinical Activity of mRNA-3927

Propionic Acidemia Clinical Trial

Official title:
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

Clinical Trial 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).

Clinical Trial Description

The study will assess long-term safety and clinical activity of mRNA-3927. Participants with PA who were previously enrolled and completed the end-of-treatment (EOT) Visit of the mRNA-3927-P101 study will have the option to enroll into this extension study provided all eligibility criteria have been met. The study will include 2 periods: 1) Treatment Period and 2) Follow-up Period (up to 2 years after the last dose of study drug). 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05130437
Study type Interventional
Source ModernaTX, Inc.
Contact Moderna Clinical Trials Support Center
Phone 1-877-777-7187
Email clinicaltrials@modernatx.com
Status Recruiting
Phase Phase 1/Phase 2
Start date November 9, 2021
Completion date December 4, 2031
View Details
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT05842837 - A Non-Interventional Post-Authorization Study of Carbaglu for the Treatment of Hyperammonemia Due to MMA and PA
Recruiting NCT05687474 - Baby Detect : Genomic Newborn Screening
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Recruiting NCT02890342 - Natural History, Physiology, Microbiome and Biochemistry Studies of Propionic Acidemia
Completed NCT02426775 - Carglumic Acid in Methylmalonic Acidemia and Propionic Acidemia Phase 3
Terminated NCT04836494 - A First in Human, Dose Escalation Study to Evaluate the Safety and Tolerability of BBP-671 in Healthy Volunteers and Patients With Propionic Acidemia or Methylmalonic Acidemia Phase 1
Completed NCT03484767 - "The MaP Study": Mapping the Patient Journey in MMA and PA
Terminated NCT04732429 - Study of HST5040 in Subjects With Propionic or Methylmalonic Acidemia Phase 2
Recruiting NCT05040178 - An Observational Study of Carbaglu® for the Treatment of MMA and PA in Adults and Pediatrics
Recruiting NCT05769621 - A Retrospective Study to Characterize Participants With Propionic Acidemia
Completed NCT00645879 - Anaplerotic Therapy in Propionic Acidemia Phase 1
Recruiting NCT04176523 - Understanding the Long-Term Management of Organic Acidemia Patients With CARBAGLU®: A Mixed Methods Approach
Withdrawn NCT01341379 - Increasing Ureagenesis in Inborn Errors of Metabolism With N-Carbamylglutamate Phase 2
Terminated NCT05438485 - Natural History Study of Patients With Methylmalonic Acidemia and Propionic Acidemia
Completed NCT03159026 - Review of Charts From Amish/Mennonite Variant PA Patients
Recruiting NCT04159103 - Open-Label Study of mRNA-3927 in Participants With Propionic Acidemia Phase 1/Phase 2