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Avalglucosidase Alfa Extension Study

NCT02032524 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2024-03-01

Study results available
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Summary

Primary Objective:

Long-term safety and pharmacokinetics (PK) of avalglucosidase alfa

Secondary Objective:

Long-term effect of avalglucosidase alfa on pharmacodynamic variables

Conditions

  • Glycogen Storage Disease Type II Pompe Disease

Interventions

DRUG

Avalglucosidase Alfa

Pharmaceutical form: lyophilized powder reconstituted for infusion Route of administration: intravenous

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-02-27
Primary Completion
2022-12-12
Completion
2022-12-12

Countries

  • United States
  • Belgium
  • Denmark
  • France
  • Germany
  • Netherlands
  • 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 NCT02032524 on ClinicalTrials.gov