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

Description

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).

Conditions

Propionic Acidemia

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Study Overview

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Study Details

Study overview

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).

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

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

Condition
Propionic Acidemia
Intervention / Treatment

-

Contacts and Locations

Ann Arbor

University of Michigan Hospitals, Ann Arbor, Michigan, United States, 48109

Durham

Duke University Medical System (Duke Health), Durham, North Carolina, United States, 27710

Philadelphia

The Children's Hospital of Philadelphia (CHOP), Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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.
  • * Not expected to receive clinical benefit from continued mRNA-3927 administration, in the opinion of the Investigator.
  • * Any clinical or laboratory abnormality or medical condition that, at the discretion of the Investigator, may put the individual at increased risk by participating in this study.
  • * History of liver and/or kidney transplant.

Ages Eligible for Study

1 Year to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ModernaTX, Inc.,

Study Record Dates

2031-12-04