Evaluation of the Long-term Safety, Pharmacodynamics, and Exploratory Efficacy of GZ/SAR402671 in Treatment-Naïve Adult Male Patients With Fabry Disease
Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
The total duration of this extension study (LTS14116) was up to 31 months (30 months of treatment and one month post-treatment follow-up).
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion 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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
8 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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