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Fabry Disease clinical trials

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NCT ID: NCT04440254 Not yet recruiting - Fabry Disease Clinical Trials

Long Duration Holter ECG in Fabry Disease

Start date: September 1, 2020
Phase: N/A
Study type: Interventional

The main objective is to assess the occurrence of cardiac arrhythmias and conduction disorders during a three-year follow-up using implantable Holter ECG monitoring in 40 patients with Fabry disease. The secondary objectives are to analyze the correlations of these anomalies with changes in cardiac MRI and echocardiographic parameters as biological parameters and overall severity of the disease assessed by MSSI.

NCT ID: NCT04281537 Completed - Fabry Disease Clinical Trials

A Study to Describe the Experience of Both Patients and Their Clinicians in the Treatment of Fabry Disease With Enzyme Replacement Therapy.

Start date: March 1, 2020
Phase:
Study type: Observational

This is an international, non-interventional research study of adult patients with Fabry Disease and their caregivers. The study will comprise a prospective time and motion evaluation and a cross-sectional evaluation of patient and caregiver-reported outcomes. The study will evaluate the time associated with the preparation and administration of a single dose of ERT in patients by health care providers as well as the impact on Fabry patients and caregivers time and costs associated with an ERT treatment. The study will also evaluate the patients' quality of life wellbeing, fatigue and work productivity.

NCT ID: NCT04252066 Recruiting - Fabry Disease Clinical Trials

A Global Prospective Observational Study of Women With Fabry Disease and Their Infants During Pregnancy and Breastfeeding

Start date: April 17, 2020
Phase:
Study type: Observational

This is a global prospective observational study of women with Fabry disease and their infants during pregnancy and/or breastfeeding. The study will evaluate outcomes of pregnancy and/or breastfeeding in women and infants exposed to migalastat.

NCT ID: NCT04189601 Withdrawn - Fabry Disease Clinical Trials

Complement Activation in the Lysosomal Storage Disorders

CATALYST
Start date: September 30, 2020
Phase:
Study type: Observational

The lysosomal storage disorders (LSDs) are monogenic disorders associated with inflammation affecting multiple organs, and early death. Few treatments are available that can modify the disease course, and there is an urgent need to identify new steps in pathogenesis that can be targeted therapeutically. The complement system is novel and highly plausible as a primary driver of inflammation and cellular injury in the LSDs. This study assesses the complement activation state in patients with Fabry disease (FD), Gaucher disease (GD) and Niemann-Pick disease, type C (NPC), with comparison to healthy controls. This has the potential for immense clinical benefit through targeted complement inhibition across the full spectrum of lysosomal storage disorders, in which key pathophysiological processes including the inflammatory response to lysosomally 'stored' materials are shared.

NCT ID: NCT04184986 Recruiting - Fabry Disease Clinical Trials

Screening of Fabry Disease in Patients With GI Symptoms

GiFD
Start date: September 1, 2019
Phase:
Study type: Observational

Fabry disease screening study in patients diagnosed with gastrointestinal tract (GIT) disease, i.e. with the diagnosis of non-infectious inflammatory bowel disease, functional dyspepsia or irritable bowel syndrome in particular, is a project designed as a pilot study of Centre for Fabry disease, General University Hospital in Prague, and Clinical Centre ISCARE Prague, focused on improving the diagnosis and care of patients with Fabry disease in the Czech Republic. Fabry disease, (FD) is an X-linked inherited, rare, progressive disorder of glycosphingolipid metabolism affecting multiple organs resulting in organ dysfunction. The earlier diagnosis is made the earlier treatment is started the better outcome patients have. There are screening programs in cardiology, nephrology, neurology or ophtalmology fields. But not only cardiovascular, renal or eye symptoms are present. Very common are also GI symptoms in Fabry disease patient population. This is the first screening of FAbry disease in GI symptom patients.

NCT ID: NCT04143958 Withdrawn - Fabry Disease Clinical Trials

To Assess the Glycosphingolipid Clearance and Clinical Effects of Switching to Agalsidase Beta (Fabrazyme) Versus Continuing on Agalsidase Alfa (Replagal) in Male Patients With Classic Fabry Disease

BCLEAR1
Start date: September 2020
Phase: Phase 4
Study type: Interventional

Primary Objective: To assess reduction of plasma lyso-GL3 level after switch to agalsidase beta from agalsidase alfa Secondary Objectives: - To assess reduction of kidney podocyte GL3 content after switch to agalsidase beta from agalsidase alfa - To assess reduction of GL3 content in endothelial skin cells after switch to agalsidase beta from agalsidase alfa - To assess change in renal function after switch to agalsidase beta from agalsidase alfa - To assess disease severity and clinical changes after switch to agalsidase beta from agalsidase alfa - To assess improvement in symptoms of Fabry disease after switch to agalsidase beta from agalsidase alfa

NCT ID: NCT04073888 Completed - Fabry Disease Clinical Trials

Study of the Spermatic Characteristics of Patients With Fabry Disease

FERTIFABRY
Start date: February 20, 2009
Phase: N/A
Study type: Interventional

The objective of this project is to estimate the prevalence of spermatic abnormalities in patients with Fabry disease.The main objective of this project is to estimate the prevalence of spermatic abnormalities in patients with Fabry disease.

NCT ID: NCT04050137 Completed - Fabry Disease Clinical Trials

Therapeutic Exercise to Treat Neuropathic Pain

Aps
Start date: May 2, 2019
Phase: N/A
Study type: Interventional

A quasi-experimental, prospective clinical trial with pre and post intervention measurements, whose porpuose is assess the efficacy of a therapeutic exercise protocol to treat neuropathic pain in Fabry Disease.

NCT ID: NCT04049760 Active, not recruiting - Fabry Disease Clinical Trials

Safety, Pharmacodynamics, and Efficacy of Migalastat in Pediatric Subjects (Aged >12 Years) With Fabry Disease

Start date: October 14, 2019
Phase: Phase 3
Study type: Interventional

This is a long-term, Open-label Study to Evaluate the Safety, Pharmacodynamics, and Efficacy of Migalastat in Subjects > 12 Years of Age With Fabry Disease and Amenable GLA Variants

NCT ID: NCT04046224 Active, not recruiting - Fabry Disease Clinical Trials

Dose-Ranging Study of ST-920, an AAV2/6 Human Alpha Galactosidase A Gene Therapy in Subjects With Fabry Disease (STAAR)

Start date: July 23, 2019
Phase: Phase 1/Phase 2
Study type: Interventional

This is the first in human treatment with ST-920, a recombinant AAV2/6 vector encoding the cDNA for human a-Gal A. The purpose of this study is to evaluate the safety and tolerability of ascending doses of ST-920. ST-920 aims to provide stable, long-term production of α-Gal A at therapeutic levels in subjects with Fabry disease. The constant production of α-Gal A in humans should, importantly, enable reduction and potentially clearance of Fabry disease substrates Gb3 and lyso-Gb3. On Day 1, patients will be infused intravenously with a single dose of ST-920 and followed for a period of 52 weeks.