Novel Inflammatory Biomarkers Complement 5A and Hepcidin in Patients With Gaucher Disease (GD)

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
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• 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.

Locations
United States
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Contact Information
Primary
Reena Kartha, PhD
rvkartha@umn.edu
612-626-2436
Time Frame
Start Date: 2015-10
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 34
Treatments
Treatment naive GD1
Type 1 Gaucher disease subjects who are naive to any treatment
Treated GD1
Type 1 Gaucher disease who are stable on therapy (on the specific ERT and/or SRT and specific dose for at least 2 years)
Healthy Volunteers (No longer recruiting)
Age matched healthy controls. No new participants will be enrolled to this arm.
Related Therapeutic Areas
Sponsors
Leads: University of Minnesota

This content was sourced from clinicaltrials.gov