Clinical Trial

Gene Transfer Study in Patients With Late Onset Pompe Disease

Study acronym: FORTIS
Active, Not Recruiting Phase 1/2
View on ClinicalTrials.gov →
Summary
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).
Protocol Amendment History 21 amendments
This ClinicalTrials.gov record has been amended 21 times since 2019-11-21; most recent amendment 2026-06-09.
Status change: Recruiting → Active, Not Recruiting 2025-03-04
Status change: Active, Not Recruiting → Recruiting 2023-02-09
Status change: Recruiting → Active, Not Recruiting 2022-07-06
Status change: Not Yet Recruiting → Recruiting 2020-07-23
Trial Details
NCT Number NCT04174105
Lead Sponsor Astellas Gene Therapies
Conditions Pompe Disease (Late-onset)
Enrollment 11 participants
Start Date 2020-10-27
Primary Completion 2035-02-28 (estimated)
Study Completion 2035-02-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-10