At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 8 enrolled
Drug / intervention
GZ/SAR402671drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating GZ/SAR402671 for Fabry Disease. Completed, enrolled 8 participants across 7 sites in 5 countries.
Detailed Summary
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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesFrance, Poland, Russia, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 2015
Enrollment StartJul 2015
Primary CompletionNov 2018
TodayJul 2026
First PostedJul 3, 2015
Enrollment StartJul 7, 2015
Primary CompletionNov 20, 2018
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 11.0 years ago
Interventions
GZ/SAR402671drug
Pharmaceutical form:capsule Route of administration: oral