Clinical Trial: A Study to Evaluate the Safety, Efficacy, PK, PD and Immunogenicity of Cipaglucosidase Alfa/Miglustat in IOPD Subjects Aged 0 to <18

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: An Open-label Study to Evaluate the Safety, Efficacy, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Cipaglucosidase Alfa/Miglustat in Both ERT-experienced and ERT-na�ve Pediatric Subj

Brief Summary: This is a Phase 3, open-label, multicenter study to evaluate the safety, efficacy, PK, PD, and immunogenicity of cipaglucosidase alfa/miglustat treatment in ERT-experienced and ERT-na�ve pediatric subjects with IOPD.

Detailed Summary:
Sponsor: Amicus Therapeutics

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Amicus Therapeutics

Dates:
Date Received: March 10, 2021
Date Started: July 18, 2023
Date Completion: July 18, 2023
Last Updated: October 05, 2023
Last Verified: August 01, 2023