A study to assess the long-term safety and efficacy of ATB200/AT2221 in adult subjects with LOPD
A study to assess the long-term safety and efficacy of ATB200/AT2221 in adult subjects with LOPD
ClinicalTrials.gov ID: NCT04138277
Sponsor: Amicus Therapeutics
Information provided by: Amicus Therapeutics (Responsible Party)
Last Update Posted: 2024-09-19
Brief Summary:
This is a multicenter, international open-label extension study of ATB200/AT2221 in adult subjects with late-onset Pompe disease (LOPD) who completed Study ATB200-03.
Detailed Description:
This is an open label extension study for subjects who completed the ATB200-03 study. The subjects will stay in this study until regulatory approval or marketing authorization and/or commercialization in the participating subject's country.
Official Title:
A Phase 3 Open-label Extension Study to Assess the Long-term Safety and Efficacy of Intravenous ATB200 Co-administered with Oral AT2221 in Adult Subjects with Late Onset Pompe Disease
Intervention / Treatment:
- Drug: AT2221
- Biological: ATB200
| Category | Value |
|---|---|
| Study Start (Actual) |
2019-12-18
|
| Primary Completion (Estimated) |
2024-12-01
|
| Study Completion (Estimated) |
2024-12-01
|
| Enrollment (Estimated) | 110 |
| Study Type | Interventional |
| Phase | Phase 3 |
| Other Study ID Numbers |
ATB200-07
|