A Phase 1/2, Open Label, Dose Ranging Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks for 12 Weeks to Adult Fabry Patients

  • STATUS
    Recruiting
Updated on 8 November 2020

Summary

A Phase 1/2, Open Label, Dose Ranging Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of PRX-102 Administered by Intravenous Infusion Every 2 Weeks for 12 Weeks to Adult Fabry Patients

Description

To evaluate the safety and tolerability of a long-term enzyme replacement therapy(ERT) – PRX-102 – in adult subjects with Fabry disease.

Details
Condition Fabry Disease
Clinical Study IdentifierTX137404
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Symptomatic adult Fabry patients (> 18 years)
Males: plasma and/or leukocyte alpha galactosidase activity (by laboratory testing) less than the lower limit of normal
Females: historical genetic tests results consistent with Fabry mutations
Males and Females with more than 1.5 times the upper normal limit of Globotriaosylceramide (Gb3) in the urine
Patients who have never received ERT or patients have not received ERT in the past six months and have a negative anti PRX-102 antibody test (will be done at Baylor)
Patients identified with a certain amount of kidney disease
Female patients and male patients whose co-partners are of child-bearing potential must agree to use study specified methods of birth control
Able to sign an informed consent
Able to travel to Baylor University Medical Center(BUMC) at least every two weeks and as required

Exclusion Criteria

Contact the study coordinator for exclusion criteria
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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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