A Study to Evaluate the Long-term Safety and Tolerability of Lucerastat in Adult Subjects With Fabry Disease



Status:Recruiting
Conditions:Hematology, Metabolic
Therapuetic Areas:Hematology, Pharmacology / Toxicology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:December 18, 2018
End Date:February 15, 2022
Contact:Clinical Trial Disclosure Desk
Email:clinical-trials-disclosure@idorsia.com
Phone:+41 58 844 0000

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A Multi-center, Open-label, Uncontrolled, Single-arm, Extension Study to Determine the Long-term Safety and Tolerability of Oral Lucerastat in Adult Subjects With Fabry Disease

A study to determine the long-term safety and tolerability of oral lucerastat in adult
subjects with Fabry disease


Inclusion Criteria:

- Signed ICF prior to any study-mandated procedure;

- Subject completed the 6-month, double-blind treatment period in study ID 069A301

- Woman of childbearing potential only if agreement 1) to follow a specified
contraception scheme, 2) to undertake monthly urine pregnancy tests , 3) not to donate
ova.

- Fertile male only if agreement 1) to use a condom, 2) to not father a child, 3) not to
donate sperm.

Exclusion Criteria:

- Pregnant / planning to be become pregnant up to 30 days after study treatment
discontinuation 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.

In addition, the subject must not be enrolled in study ID-069A302 if at any time during
study ID-069A301, one of the following criteria was met:

- Subject's eGFR per the Chronic Kidney Disease Epidemiology Collaboration creatinine
equation < 15 mL/min/1.73 m2;

- Subject experienced an event of acute kidney injury Common Terminology Criteria for
Adverse Event (CTCAE) grade 2 or above;

- Subject experienced an event of stroke CTCAE grade 3 or above;

- Subject experienced an event of heart failure leading to in-patient hospitalization or
prolongation of ongoing hospitalization.
We found this trial at
12
sites
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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3959 Pender Drive
Fairfax, Virginia 22030
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Irvine, California 92697
949-824-5011
University of California, Irvine Since 1965, the University of California, Irvine has combined the strengths...
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515 Delaware Street Southeast
Minneapolis, Minnesota 55455
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