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Gene Transfer Study in Patients With Late Onset Pompe Disease

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

Record History

See every version on ClinicalTrials.gov ↗

  1. Minor 2 versions Re-verified since Jun 9, 2026, no change to tracked fieldsv22-v23
  2. Notable Primary and study completion dates: Feb 28, 2030 to Feb 28, 2035
    • Study description revised
    v21
  3. Minor Re-verified, no change to tracked fieldsv20
  4. Minor Eligibility criteria expanded, about 11 wordsv19
  5. Minor Trial status: Recruiting to Active, Not Recruitingv18 Show 4 more changesShow less
    • Enrollment target: estimated 18 to confirmed 11
    • Primary and study completion dates: Nov 30, 2029 to Feb 28, 2030
    • Eligibility criteria expanded, about 133 words
    • Site details revised at 4 of 4 sites
Show 16 earlier versionsHide 16 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv17
  2. Notable Enrollment target: 12 to 18
    • Primary and study completion dates: Sep 30, 2029 to Nov 30, 2029
    • Eligibility criteria expanded, about 122 words
    • Secondary endpoints: 10 to 11
    v16
  3. Minor Primary and study completion dates: Aug 31, 2029 to Sep 30, 2029v15
  4. Minor Primary and study completion dates: Apr 30, 2029 to Aug 31, 2029v14
  5. Minor Interventions: AT845 (Genetic) to zocaglusagene nuzaparvovec (Genetic)v13
  6. Notable Primary completion date: May 31, 2025 to Apr 30, 2029
    • Study completion date: May 31, 2029 to Apr 30, 2029
    v12
  7. Minor Primary completion date: Dec 31, 2024 to May 31, 2025
    • Study completion date: Nov 30, 2028 to May 31, 2029
    v11
  8. Minor Eligibility criteria expanded, about 378 words
    • Secondary endpoints: details revised at 2 of 10 entries
    • Site contacts updated at 4 of 4 sites
    v10
  9. Notable Trial status: Active, Not Recruiting to Recruitingv9 Show 4 more changesShow less
    • Primary completion date: Dec 2022 to Dec 31, 2024
    • Study sites: 6 to 4
    • Study completion date: Jan 2027 to Nov 30, 2028
    • Start date: Oct 28, 2020 to Oct 27, 2020
  10. Notable Lead sponsor: Audentes Therapeutics to Astellas Gene Therapies
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 6 of 6 sites
    v8
  11. Notable Enrollment target: 8 to 12v7 Show 5 more changesShow less
    • Study sites: 8 to 6
    • Secondary endpoints: 9 to 10
    • Primary endpoints revised (3)
    • Study description expanded, about 42 words
    • Study arms: 2 to 3
  12. Minor Site details revised at 1 of 8 sitesv6
  13. Minor Site contacts updated at 1 of 8 sitesv5
  14. Minor Study sites: 5 to 8
    • Start date changed from estimate of Aug 2020 to Oct 28, 2020
    • Secondary endpoints: details revised at 1 of 9 entries
    • Study description revised
    v4
  15. Minor Start date: Jul 2020 to Aug 2020
    • Site contacts updated at 1 of 5 sites
    v3
  16. Notable Trial status: Not Yet Recruiting to Recruitingv2 Show 8 more changesShow less
    • Start date: Mar 2020 to Jul 2020
    • Primary endpoints revised (3)
    • Study sites: 0 to 5
    • Primary completion date: Mar 2023 to Dec 2022
    • Study completion date: Mar 2026 to Jan 2027
    • Eligibility criteria expanded, about 253 words
    • Secondary endpoints: 2 to 9
    • Study description expanded, about 116 words
  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.
This is a phase 1/2 open-label, ascending dose, multicenter clinical study to evaluate the safety and efficacy of AT845 in adult (aged ≥ 18 years) subjects, ambulatory or nonambulatory, with Late Onset Pompe Disease (LOPD).
Trial Details
NCT Number NCT04174105
Lead Sponsor Astellas Gene Therapies
Conditions
(from sponsor)
Pompe Disease (Late-onset)
Related terms Glycogen Storage Disease Type II
Enrollment 11 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov