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NOT YET RECRUITING
NCT06575829
PHASE4

Treatment Frequency Reduction in Pompe Disease

Sponsor: Erasmus Medical Center

View on ClinicalTrials.gov

Summary

The aim of this study is to assess if dosing frequency reduction of alglucosidase alfa 20 mg/kg once every 2 weeks to once every 4 weeks is safe and does not lead to increased progression of disease in a selected group of patients with late-onset Pompe disease.

Official title: Open Label, Single-center Pilot Study to Investigate Alglucosidase Alfa (20 mg/kg) Frequency Reduction From 2 to 4 Weeks in a Subgroup of Elderly Patients With Late-onset Pompe Disease (TRIPOD-Study)

Key Details

Gender

All

Age Range

50 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2024-10-01

Completion Date

2027-12-31

Last Updated

2024-08-28

Healthy Volunteers

No

Interventions

DRUG

Algucosidase alfa 20 mg/kg once every 4 weeks instead of once every 2 weeks

The interval of ERT with alglucosidase alfa will be extended from once every 2 weeks to once every 4 weeks. The dose of 20 mg/kg per infusion remains the same.