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:
2025-12-24 @ 10:36 PM
Ignite Modification Date:
2025-12-24 @ 10:36 PM
NCT ID:
NCT00041535
Eligibility Criteria:
* INCLUSION CRITERIA:
Patients with neuronopathic Gaucher disease, confirmed by clinical diagnosis, who if receiving enzyme replacement therapy have been stable on enzyme replacement therapy for at least 6 months or have successfully undergone a bone marrow transplant at least one year prior to study entry.
Patients who are at least 4 years old and can swallow a capsule.
EXCLUSION CRITERIA:
Patients younger than 18 years who are unable to give informed assent and/or whose legal guardian is unable to provide informed consent.
Patients aged 18 and over who cannot provide informed consent and/or whose legal guardian is unable to provide witnessed informed consent.
Fertile patients, who at the time of the study could be sexually active, and who do not agree to use adequate contraception throughout the study and for three months after cessation of OGT 918 treatment.
Patients who cannot tolerate the study procedures or who are unable to travel to the study center as required by this protocol.
Patients currently undergoing therapy with other investigational agents or patients taking drugs or food supplements which may interfere with gastrointestinal absorption or motility.
Patients suffering from clinically significant diarrhea (greater than 3 liquid stools per day for greater than 7 days) without definable cause within 3 months of the Screening Visit, or who have a history of significant gastrointestinal disorders.
Patients with an intercurrent medical condition that would render them unsuitable for the study e.g. HIV, hepatitis infection.
Patients who in the opinion of the investigator (for whatever reason) are thought to be unsuitable for the study.
Patients with an adjusted Creatinine Clearance of less than 70 ml/min/1.73m(2) (CrCl less than 70).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Study:
NCT00041535
Study Brief:
Protocol Section:
NCT00041535