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A Study of PBFT02 in Participants With FTD and Mutations in the Granulin Precursor (GRN) or C9ORF72 Genes

Study acronym: upliFT-D
StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Site details revised at 10 of 10 sites
    v23
  2. Study sites: 9 to 10v22
  3. Study sites: 8 to 9v21
  4. Study sites: 7 to 8v20
  5. Enrollment target: 25 to 30
    • Eligibility criteria shortened, about 17 words
    • Secondary endpoints revised (6)
    • Site contacts updated at 2 of 7 sites
    v19
Show 17 earlier versionsHide 17 earlier versions
  1. Enrollment target: 15 to 25v18 Show 9 more changesShow less
    • Primary completion date: Aug 2024 to Aug 2028
    • Primary endpoints: 5 to 3
    • Study sites: 8 to 7
    • Study completion date: Aug 2027 to Aug 2031
    • Eligibility criteria expanded, about 148 words
    • Secondary endpoints: 23 to 6
    • Study description shortened, about 16 words
    • Study arms: 3 to 2
    • Study title expanded, about 5 words
  2. Site contacts updated at 1 of 8 sitesv17
  3. Site contacts updated at 1 of 8 sitesv16
  4. Site details revised at 1 of 8 sitesv15
  5. Site details revised at 2 of 8 sitesv14
  6. Site details revised at 1 of 8 sitesv13
  7. Study sites revised (8)v12
  8. Site contacts updated at 1 of 8 sitesv11
  9. Study sites: 7 to 8v10
  10. Site details revised at 1 of 7 sitesv9
  11. Enrollment target: 6 to 15
    • Primary endpoints revised (5)
    • Study sites: 9 to 7
    v8
  12. Site details revised at 1 of 9 sitesv7
  13. Site details revised at 1 of 9 sitesv6
  14. Re-verified, no change to tracked fieldsv5
  15. Primary endpoints: 8 to 5v4 Show 5 more changesShow less
    • Study sites: 8 to 9
    • Start date changed from estimate of Sep 2021 to Sep 14, 2021
    • Eligibility criteria shortened, about 20 words
    • Secondary endpoints revised (23)
    • Study description expanded, about 4 words
  16. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 2021 to Sep 2021
    • Site details revised at 8 of 8 sites
    v3
  17. Study title expanded, about 1 wordv2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
PBFT02 is a gene therapy for frontotemporal dementia intended to deliver a functional copy of the GRN gene to the brain. This study will assess the safety, tolerability and efficacy of this treatment in patients with frontotemporal dementia and mutations in the granulin precursor (GRN) or chromosome 9 open reading frame 72 (C9ORF72) genes
Trial Details
NCT Number NCT04747431
Lead Sponsor Passage Bio, Inc.
Conditions
(from sponsor)		 Frontotemporal Dementia, FTD, FTD-GRN, Dementia Frontotemporal, C9orf72
Related terms Frontotemporal Dementia, Frontotemporal Dementia With Motor Neuron Disease, Pick Disease of the Brain
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov