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

StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Study sites: 12 to 22v14
  2. Notable Primary endpoints: 2 to 1v13 Show 4 more changesShow less
    • Enrollment target: 36 to 50
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints: 14 to 4
    • Study description shortened, about 6 words
  3. Minor Study sites: 9 to 12v12
  4. Minor Re-verified, no change to tracked fieldsv11
  5. Minor Study sites: 6 to 9v10
Show 8 earlier versionsHide 8 earlier versions
  1. Notable Primary endpoints: 1 to 2
    • Secondary endpoints: 10 to 14
    • Study sites revised (6)
    • Study title expanded, about 7 words
    v9
  2. Minor Study sites: 7 to 6v8
  3. Minor Study sites: 5 to 7v7
  4. Minor Re-verified, no change to tracked fieldsv6
  5. Minor Study sites: 4 to 5v5
  6. Minor Study sites: 2 to 4v4
  7. Minor Study sites: 1 to 2v3
  8. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
49 trials monitored
See 3 trials at risk
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).
Trial Details
NCT Number NCT05130437
Lead Sponsor ModernaTX, Inc.
Conditions
(from sponsor)
Propionic Acidemia
Related terms Acid-Base Imbalance, Acidosis, Amino Acid Metabolism, Inborn Errors, Genetic Diseases, Inborn, Metabolic Diseases, Metabolism, Inborn Errors, Propionic Acidemia
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov