A Prospective Study to Investigate Safety and Tolerability of Shorter Infusion of Fabrazyme

  • STATUS
    Recruiting
  • End date
    Oct 6, 2025
  • participants needed
    18
  • sponsor
    Sanofi
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Updated on 7 March 2024
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Summary

This Phase 4 study will evaluate the safety and tolerability of Fabrazyme at current approved dose with increases in the infusion rate and reduced infusion volume. This study aims to generate data to provide the guidance on how infusion rate can be safely increased and minimize the burden of the life-long treatment with Fabrazyme.

Description

The total duration will be up to 6 months

Details
Condition Fabry's Disease
Age 2years - 65years
Treatment Dexamethasone, Montelukast, Acetaminophen, Diphenhydramine, Agalsidase beta (GZ419828)
Clinical Study IdentifierNCT06019728
SponsorSanofi
Last Modified on7 March 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Participants with confirmed diagnosis of FD who are ≥2 and ≤65 years of age at the time of signing the informed consent form (ICF) or assent, if applicable
Cohort 1: female participants with body weight ≥30 kg who have been treated with Fabrazyme for at least 3 months without IARs during the most recent 3 infusions
Cohort 2: non-classic male participants with body weight ≥30 kg who have been treated with Fabrazyme for at least 3 months without IARs during the most recent 3 infusions
Cohort 3: classic male participants with body weight ≥30 kg who have been treated with Fabrazyme for at least 3 months without IARs during the most recent 3 infusions
Cohort 4: participants with body weight <30 kg who have been treated with Fabrazyme for at least 3 months without IARs during the most recent 3 infusions
Cohort 5: ERT-naïve participants. Women of childbearing potential must use a highly effective method of contraception through the study

Exclusion Criteria

Female participants who are pregnant or breastfeeding
History of significant allergic disease or hypersensitivity to Fabrazyme or other medicinal products
Contraindication to Fabrazyme or any of the premedications or rescue medications (diphenhydramine, acetaminophen, montelukast, dexamethasone)
Any other medical condition considered to make the increased infusion rate not tolerable at the Investigator's discretion. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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