NCT02437396Recruiting
Oxidative Stress and Inflammatory Biomarkers in Gaucher Disease
Novel Inflammatory Biomarkers Complement 5A and Hepcidin in Patients With Gaucher Disease (GD)
Source: ClinicalTrials.gov · Last updated 13 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 34 (estimated)
- First submitted
- 4 May 2015
- Start date
- 1 Oct 2015
- Primary completion date
- 30 Oct 2026
- Lead sponsor
- University of Minnesota
- Diseases
- Gaucher disease
- NCT number
- NCT02437396
What you commit to
- Study type: Observational
- Planned participants: 34
- From 1 Oct 2015 to the primary completion date, 30 Oct 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Medically unstable conditions in any group as determined by the investigators
- History of asthma that is presently being treated
Age
- Females who are pregnant or lactating or of child-bearing age who are not using acceptable forms of contraception
Other
- Subjects who cannot or are unwilling to have blood drawn
- Unable to adhere to study protocol for whatever reason
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.