Evaluation of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-Naïve Adult Male Patients With Fabry Disease
| Status: | Completed |
|---|---|
| Conditions: | Hematology, Metabolic |
| Therapuetic Areas: | Hematology, Pharmacology / Toxicology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/11/2019 |
| Start Date: | July 7, 2015 |
| End Date: | November 20, 2018 |
An Open-label, Multicenter, Multinational Extension Study of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Adult Male Patients Diagnosed With Fabry Disease
Primary Objective:
To assess the long-term safety of GZ/SAR402671 in adult male patients with Fabry disease who
previously completed study ACT13739.
Secondary Objective:
To assess the long-term effect of GZ/SAR402671 on pharmacodynamic and exploratory efficacy
endpoints in adult male patients with Fabry disease who previously completed study ACT13739.
To assess the long-term safety of GZ/SAR402671 in adult male patients with Fabry disease who
previously completed study ACT13739.
Secondary Objective:
To assess the long-term effect of GZ/SAR402671 on pharmacodynamic and exploratory efficacy
endpoints in adult male patients with Fabry disease who previously completed study ACT13739.
The total duration of study period will be up to 31 months.
Inclusion criteria :
- Male patient with Fabry disease who previously completed study ACT13739.
- Patients, willing and able to provide signed informed consent.
- Sexually active patients, willing to practice true abstinence in line with their
preferred and usual lifestyle or using two acceptable effective methods of
contraception.
Exclusion criteria :
-Patients, in the opinion of the Investigator, unable to adhere to the requirements of the
study.
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
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