At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 11 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.
A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Exploratory Efficacy of GZ/SAR402671 in Enzyme Replacement Therapy (ERT) Treatment-naïve Adult Male Patients Diagnosed With Fabry Disease
In Brief
A Phase 2 clinical trial evaluating GZ/SAR402671 for Fabry Disease. Completed, enrolled 11 participants across 8 sites in 5 countries.
Detailed Summary
Primary Objective: To assess the safety, pharmacokinetics (PK), pharmacodynamics (PD), and exploratory efficacy of GZ/SAR402671 in enzyme replacement therapy treatment-naïve adult male participants diagnosed with Fabry disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFabry Disease
CountriesFrance, Poland, Russia, United Kingdom, United States
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 2014
Enrollment StartNov 2014
Primary CompletionSep 2016
TodayJul 2026
First PostedAug 29, 2014
Enrollment StartNov 1, 2014
Primary CompletionSep 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.8 years ago
Interventions
GZ/SAR402671drug
Pharmaceutical form: Capsule; Route of administration: Oral