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

Completed · Phase 2

Conditions studied: Fabry Disease

In brief

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.

Key facts

Study ID

NCT02489344

Run by

Genzyme, a Sanofi Company

People needed

8

Starts

2015-07-07

Expected to finish

2018-11-20

Last updated by the study team

2021-03-23

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Investigational Site Number 840002 — Atlanta, Georgia, United States
• Investigational Site Number 840003 — Cincinnati, Ohio, United States
• Investigational Site Number 840001 — Fairfax, Virginia, United States
• Investigational Site Number 250001 — Garches, France
• Investigational Site Number 616001 — Warsaw, Poland
• Investigational Site Number 643002 — Moscow, Russia
• Investigational Site Number 826002 — Cambridge, United Kingdom

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.