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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502911-12-00 | Other Identifier | Clinical Trials Information System (CTIS) |
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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).
The study will assess long-term safety of mRNA-3927. Participants with PA who were previously enrolled and completed the end-of-treatment (EOT)/early termination (ET) 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 (90 days after the EOT visit). 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mRNA-3927 | Experimental | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-3927 | Biological | mRNA-3927 dispersion for IV infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Adverse Events (AEs), Serious AEs (SAEs), and AEs Leading to Discontinuation | Baseline through End of Study Visit (up to 8 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Annualized Frequency of Investigator-reported Metabolic Decompensation Events (MDEs) | Baseline through End of Study Visit (up to 8 years) | |
| Annualized Frequency of Investigator-reported MDE-related Hospitalizations | Baseline through End of Study Visit (up to 8 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Moderna WeCare Team | Contact | 1-866-663-3762 | WeCareClinicalTrials@modernatx.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ronald Reagan UCLA Medical Center | Not yet recruiting | Los Angeles | California | 90095 | United States | |
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| Annualized Frequency of Investigator-reported PA-related Hospitalizations | Baseline through End of Study Visit (up to 8 years) |
| Annualized Frequency of Investigator-reported PA-related Urgent Healthcare Encounters | Baseline through End of Study Visit (up to 8 years) |
| University of Stanford Medical Center |
| Recruiting |
| Palo Alto |
| California |
| 94304-1503 |
| United States |
| University of Michigan Hospitals | Recruiting | Ann Arbor | Michigan | 48109 | United States |
| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
| Duke University Medical System (Duke Health) | Recruiting | Durham | North Carolina | 27710 | United States |
| The Children's Hospital of Philadelphia (CHOP) | Recruiting | Philadelphia | Pennsylvania | 19104 | United States |
| Texas Children's Hospital | Recruiting | Houston | Texas | 77030 | United States |
| Hospital For Sick Children | Recruiting | Toronto | Ontario | M5G 1X8 | Canada |
| AP-HM- Hôpital de La Timone | Not yet recruiting | Marseille | 13005 | France |
| Hôpital Necker - Enfants Malades | Not yet recruiting | Paris | 75019 | France |
| Fujita Health University Hospital | Recruiting | Toyoake-shi | Akita | 470-1192 | Japan |
| Tohoku University Hospital | Recruiting | Sendai | Miyagi | 980-8574 | Japan |
| Erasmus MC -Dr. Molewaterplein 40 | Not yet recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
| Universitair Medisch Centrum Utrecht - PPDS | Not yet recruiting | Utrecht | 3584 CX | Netherlands |
| King Faisal Specialist Hospital & Research Centre | Not yet recruiting | Riyadh | Ar Riya | 11211 | Saudi Arabia |
| King Abdullah Children's Specialist Hospital | Not yet recruiting | Riyadh | Ar Riya | 14611 | Saudi Arabia |
| Hospital Universitario Cruces | Not yet recruiting | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital Universitario 12 de Octubre | Not yet recruiting | Madrid | 28041 | Spain |
| Willink Biochemical Genetics Unit - Manchester | Recruiting | Manchester | England | M13 9WL | United Kingdom |
| University Hospital Birmingham NHS Foundation Trust | Recruiting | Birmingham | West Midlands | B15 2TH | United Kingdom |
| Birmingham Women's and Children's NHS Foundation Trust | Completed | Birmingham | West Midlands | B4 6NH | United Kingdom |
| Great Ormond Street Hospital for Children NHS Foundation Trust | Recruiting | London | WC1N 3JH | United Kingdom |
| ID | Term |
|---|---|
| D056693 | Propionic Acidemia |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D000592 | Amino Acid Metabolism, Inborn Errors |
| D000138 | Acidosis |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009750 | Nutritional and Metabolic Diseases |
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