BridgeMD
A study to determine the long-term safety and tolerability of oral lucerastat in adult subjects with Fabry disease
EU CTIS ID: 2024-513884-20-00
What this study is testing
To determine the long-term safety and tolerability of lucerastat in subjects with Fabry disease
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed and dated ICF prior to any study-mandated procedure;
- Subject completed the 6-month, double-blind treatment period in study ID 069A301;
You likely can't join if
- Pregnant / planning to become pregnant or lactating subject;
- Subject considered to be at high risk of developing clinical signs of organ involvement within the time period of the study, as per investigator judgment;
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results as per investigator judgment.
- If at any time during study ID-069A301, the following criteria was met: Subject’s eGFR per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation < 15 mL/min/1.73 m2.
- If at any time during study ID-069A301, the following criteria was met: Subject experienced an event of acute kidney injury Common Terminology Criteria for Adverse Event (CTCAE) grade 2 or above;
- If at any time during study ID-069A301, the following criteria was met: Subject experienced an event of stroke CTCAE grade 3 or above;
See the full eligibility criteria
- Signed and dated ICF prior to any study-mandated procedure;
- Subject completed the 6-month, double-blind treatment period in study ID 069A301;
- Pregnant / planning to become pregnant or lactating subject;
- Subject considered to be at high risk of developing clinical signs of organ involvement within the time period of the study, as per investigator judgment;
- Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results as per investigator judgment.
- If at any time during study ID-069A301, the following criteria was met: Subject’s eGFR per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation < 15 mL/min/1.73 m2.
- If at any time during study ID-069A301, the following criteria was met: Subject experienced an event of acute kidney injury Common Terminology Criteria for Adverse Event (CTCAE) grade 2 or above;
- If at any time during study ID-069A301, the following criteria was met: Subject experienced an event of stroke CTCAE grade 3 or above;
- If at any time during study ID-069A301, the following criteria was met: Subject experienced an event of heart failure leading to in-patient hospitalization or prolongation of ongoing hospitalization.
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United Kingdom
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United Kingdom; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.