RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

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

Quick Facts

Study Start:2021-11-09
Study Completion:2031-12-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05130437

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.

Ages Eligible for Study:1 Year
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participated in Study mRNA-3927-P101.
  2. * Completed the EOT Visit in Study mRNA-3927-P101 within 10 days of first dose of mRNA-3927 in current study.
  1. * Not expected to receive clinical benefit from continued mRNA-3927 administration, in the opinion of the Investigator.
  2. * 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.
  3. * History of liver and/or kidney transplant.

Contacts and Locations

Study Contact

Moderna Clinical Trials Support Center
CONTACT
1-877-777-7187
clinicaltrials@modernatx.com

Study Locations (Sites)

University of Michigan Hospitals
Ann Arbor, Michigan, 48109
United States
Duke University Medical System (Duke Health)
Durham, North Carolina, 27710
United States
The Children's Hospital of Philadelphia (CHOP)
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: ModernaTX, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-09
Study Completion Date2031-12-04

Study Record Updates

Study Start Date2021-11-09
Study Completion Date2031-12-04

Terms related to this study

Keywords Provided by Researchers

  • mRNA-3927
  • Propionic Aciduria
  • Metabolism, Inborn Errors
  • Genetic Diseases
  • Inborn Amino Acid Metabolism, Inborn Errors
  • Acidosis
  • Acid-Base Imbalance
  • Metabolic Diseases
  • Organic Acidemias
  • Moderna
  • mRNA

Additional Relevant MeSH Terms

  • Propionic Acidemia