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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02437396
Other study ID # 1305M34501
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 2015
Est. completion date December 2024

Study information

Verified date January 2024
Source University of Minnesota
Contact Reena Kartha, PhD
Phone 612-626-2436
Email rvkartha@umn.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

We will determine oxidative stress and/or inflammation related biomarkers in whole blood and/or plasma in adult subjects with Gaucher disease. Fifteen milliliter blood sample will be collected during three independent visits over a period of approximately 3 months. These samples will be processed to separate plasma from red blood cells and frozen until assays are performed. Standardized immunoassay methods and LC/MS based methods will be adopted to assay a series of biomarkers in these samples. These data will be correlated with currently used diagnostic biomarkers.


Recruitment information / eligibility

Status Recruiting
Enrollment 35
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion criteria: 1. All participants must be 18 years or older. 2. 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. 3. Individuals with Gaucher disease who are medically stable for participation in study in the opinion of the investigator. 4. 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). 5. 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. 6. All participants must not have taken antioxidants coenzyme Q-10, vitamin C, or vitamin E for 3 weeks prior to the study. Exclusion Criteria: 1. Medically unstable conditions in any group as determined by the investigators 2. 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. 3. Females who are pregnant or lactating or of child-bearing age who are not using acceptable forms of contraception 4. History of asthma that is presently being treated 5. Subjects who cannot or are unwilling to have blood drawn 6. Unable to adhere to study protocol for whatever reason

Study Design


Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Plasma C5a Concentration Outcome will be reported as the change in plasma concentration of C5a (ng/ml) from baseline to 6 months in participants with Gaucher disease type 1 6 months
Primary Change in Plasma Hepcidin Concentration Outcome will be reported as the change in plasma concentration of hepcidin (ng/ml) from baseline to 6 months in participants with Gaucher disease type 1 6 months
Secondary Change in Blood Glutathione Concentration Outcome will be reported as the change in blood concentration of glutathione (umol/g) from baseline to 6 months in participants with Gaucher disease type 1 6 months
Secondary Change in Plasma Tumor Necrosis Factor (TNF)-alpha Concentration Outcome will be reported as the change in blood concentration of TNF-alpha (pg/ml) from baseline to 6 months in participants with Gaucher disease type 1 6 months
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