Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT04049760
Eligibility Criteria:
Inclusion Criteria:
* Male or female subjects diagnosed with Fabry disease \> 12 years of age who completed Study AT1001-020
* Subject's parent or legally-authorized representative is willing and able to provide written informed consent and authorization for use and disclosure of personal health information or research-related health information, and subject provides assent, if applicable
* If of reproductive potential, both male and female subjects agreed to use a medically accepted method of contraception throughout the duration of the study and for up to 30 days after their last dose of migalastat
Exclusion Criteria:
* Subject's last available estimated glomerular filtration rate (eGFR) in the previous study was \< 60 mL/min/1.73 m2
* Subject had advanced kidney disease requiring dialysis or kidney transplantation
* Subject received any investigational/experimental drug, biologic, or device within 30 days before baseline, with the exception of migalastat
* Subject anticipated starting gene therapy during the study period
* Subject had any intercurrent illness or condition at Visit 1 that may have precluded the subject from fulfilling the protocol requirements or suggested to the investigator that the potential subject may have an unacceptable risk by participating in this study
* Subject had a history of allergy or sensitivity to migalastat (including excipients) or other iminosugars (eg, miglustat, miglitol)
* Subject required treatment with Replagal® (agalsidase alfa) or Fabrazyme® (agalsidase beta)
* Subject required treatment with Glyset® (miglitol) or Zavesca® (miglustat)
* Female subject was pregnant or breast-feeding, or was planning to become pregnant during the study period
* In the opinion of the investigator, the subject and/or parent or legally-authorized representative was unlikely or unable to comply with the study requirements
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
17 Years
Study:
NCT04049760
Study Brief:
Protocol Section:
NCT04049760