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Evaluation of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-Naïve Adult Male Patients With Fabry Disease

NCT02489344

CompletedPhase 2

Sponsor: Genzyme, a Sanofi Company

Conditions: Fabry Disease

Interventions: GZ/SAR402671

Countries: United States, France, Poland, Russia, United Kingdom

Primary Objective: To assess the long-term safety of GZ/SAR402671 in adult male participants with Fabry disease who previously completed study ACT13739 (NCT02489344). Secondary Objective: To assess the long-term effect of GZ/SAR402671 on pharmacodynamic and exploratory efficacy endpoints in adult male participants with Fabry disease who previously completed study ACT13739.

Eligibility overview

Sex: MALE

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion criteria :

* Male participant with Fabry disease who previously completed study ACT13739.
* Participants, willing and able to provide signed informed consent.
* Sexually active participants, willing to practice true abstinence in line with their preferred and usual lifestyle or using two acceptable effective methods of contraception.

Exclusion criteria :

-Participants, in the opinion of the Investigator, unable to adhere to the requirements of the study.

The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Locations (7)

Atlanta, Georgia, United States
Cincinnati, Ohio, United States
Fairfax, Virginia, United States
Garches, France
Warsaw, Poland
Moscow, Russia
Cambridge, United Kingdom