CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 21 enrolled
Drug / intervention
alglucosidase alfabiological
Likely dose
alglucosidase alfa 20mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01410890
NCT01410890Phase 4Completed
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A Phase 3/4 Prospective Study to Characterize the Pharmacokinetics of Alglucosidase Alfa in Patients With Pompe Disease

Genzyme, a Sanofi Company·interventional·Posted Aug 5, 2011·Updated Mar 28, 2022

In Brief

A Phase 4 clinical trial evaluating alglucosidase alfa for Pompe Disease and Glycogen Storage Disease Type II (GSD II). Completed, enrolled 21 participants across 12 sites in 6 countries.

Detailed Summary

* The primary objective of this study was to characterize the pharmacokinetics (PK) of alglucosidase alfa manufactured at the 4000 L scale in participants who had a confirmed diagnosis of Pompe disease. * A secondary objective of this study was to evaluate and explore the relationship between anti-recombinant human acid alpha-glucosidase antibody titers and the PK of alglucosidase alfa.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPompe Disease, Glycogen Storage Disease Type II (GSD II)
CountriesBulgaria, India, Russia, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 5, 2011
Enrollment StartNov 3, 2014
Primary CompletionNov 20, 2020
TodayJul 2, 2026
Enrollment to primary: 6.0 yearsPosted 14.9 years ago

Interventions

alglucosidase alfabiological

Intravenous (IV) infusion of 20mg/kg body weight every other week (qow)