Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started

Description

Summary

The objective of this treatment protocol is to provide guidance to Treating Physicians who seek access to pegunigalsidase alfa for Fabry patients whose clinical condition, in the opinion of the Treating Physician, requires treatment with enzyme replacement therapy (ERT) with pegunigalsidase alfa and a) cannot be adequately treated with currently approved FDA products and/or b) are not able or willing to participate in any of the on-going clinical trials in the United States.

Official Title

Expanded Access Treatment With Open-Label Pegunigalsidase Alfa for Fabry Patients

Keywords

Fabry Disease, Pegunigalsidase alfa

Eligibility

Locations

  • University of California Irvine
    Orange California 92868 United States
  • Central Coas Nephrology
    Salinas California 93901 United States

Details

Status
not accepting new patients
Start Date
Sponsor
Chiesi Farmaceutici S.p.A.
ID
NCT04552691
Study Type
Expanded Access
Last Updated