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COMparative Enzyme replacement Trial with neoGAA versus rhGAA – COMET

COMparative Enzyme replacement Trial with neoGAA versus rhGAA – COMET

About this clinical trial

Pompe disease is an inherited disorder caused by the buildup of a complex sugar called glycogen in the body’s cells, due to the inability of the body to produce the enzyme which would normally break this sugar down. The buildup of glycogen in certain organs and tissues, especially muscles, damages their ability to function normally.

This trial will determine the effect of avalglucosidase alfa treatment on respiratory muscle strength measured as compared to alglucosidase alfa in participants with late onset Pompe disease.

Patients Required

Estimated completion

Follow-up completed 2021

Total participants required

Closed to recruitment

Study location

The Wesley Hospital

Trial title

A Phase 3 randomized, multicenter, multinational, double-blinded study comparing the efficacy and safety of repeated biweekly infusions of  neoGAA (GZ402666) and alglucosidase alfa in treatment-naïve patients with late onset Pompe disease

Eligibility

Inclusion criteria:

  1. Patient has confirmed acid alpha-glucosidase (GAA) enzyme deficiency from any tissue source and/or 2 confirmed GAA gene mutations 

Additional information

You can find out more about the WVE-004 trial by visiting the ClinicalTrials.gov website.

Lead investigator

Dr Robert Henderson

If you would like more information about this clinical trial, please complete the COMET contact form

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Wesley Medical Research

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