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Pharmacokinetics of Alglucosidase Alfa in Patients With Pompe Disease

NCT01410890 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2022-03-28

Study results available
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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.

Conditions

  • Pompe Disease
  • Glycogen Storage Disease Type II (GSD II)

Interventions

BIOLOGICAL

alglucosidase alfa

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

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-03
Primary Completion
2020-11-20
Completion
2020-11-20

Countries

  • United States
  • Bulgaria
  • India
  • Russia
  • Ukraine
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01410890 on ClinicalTrials.gov