Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease (NCT02437396) | Clinical Trial Compass
RecruitingNot Applicable
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
United States34 participantsStarted 2015-10
Plain-language summary
The objective of this study is to evaluate oxidative stress and/or inflammation in patients with Gaucher disease type I using a series of biomarkers and correlate with measurements of currently used diagnostic biomarkers.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. All participants must be 18 years or older.
✓. All enrollees must understand and cooperate with requirements of the study in the opinion of the investigators and must be able to provide written informed consent.
✓. Individuals with Gaucher disease who are medically stable for participation in study in the opinion of the investigator.
✓. GD subjects must be stable on a specific ERT and/or SRT therapy at a specific dose (for e.g. on a units/kg basis) for at least 2 years or be naïve to these therapies (no therapy for 2 years).
✓. GD1 patients, who have had a change in therapy i.e. a change in dose or switch from one drug to another, can be enrolled after at least 6 months have elapsed since the change and is considered stable in the opinion of the clinician providing care to the patient.
✓. All participants must not have taken antioxidants coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study.
Exclusion criteria
✕. Medically unstable conditions in any group as determined by the investigators
✕. Concurrent disease; medical condition; or an extenuating circumstance that, in the opinion of the investigator, might compromise subject safety, study compliance, completion of the study, or the integrity of the data collected for the study.
✕. Females who are pregnant or lactating or of child-bearing age who are not using acceptable forms of contraception