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Treatment Protocol of Replagal for Patients With Fabry Disease

NCT01031173 · Status: NO_LONGER_AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2021-05-24

No results posted yet for this study

Summary

The study will evaluate the safety and efficacy of Replagal® (agalsidase alfa) at a dose of 0.2 mg/kg infused intravenously (IV) over 40 minutes, every other week. The study will monitor the course of disease in males and females with Fabry disease who are naive to treatment or were previously treated with agalsidase beta (Fabrazyme®).

Conditions

Interventions

BIOLOGICAL

agalsidase alfa

0.2 mg/kg body weight, administered by an intravenous infusion over 40 minutes, every other week.

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT01031173 on ClinicalTrials.gov