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NCT02437396
Novel Inflammatory Biomarkers Complement 5A and Hepcidin in Patients With Gaucher Disease (GD)
trial in Gaucher Disease Type I in 34 participants. Currently enrolling.
28 June 2026
Quick facts
| Lead sponsor | University of Minnesota |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 34 |
| Start date | 1 October 2015 |
| Primary completion | 28 June 2026 |
| Estimated completion | 28 June 2026 |
| Sites | 1 location across United States |
Conditions studied
- Gaucher Disease Type I — all drugs for Gaucher Disease Type I →
- Oxidative Stress — all drugs for Oxidative Stress →
- Inflammation — all drugs for Inflammation →
Sponsor
University of Minnesota
Who can join
Adults 18 to 75, any sex, with Gaucher Disease Type I or Oxidative Stress. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change in Plasma C5a Concentration
Time frame: 6 months
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 -
Change in Plasma Hepcidin Concentration
Time frame: 6 months
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
Sponsor's own description
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.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Antimicrobial peptides: from discovery to developmental applications.
Zhang Q. · · 2025 · cited 20× · PMID 40178173 · DOI 10.1128/aem.02115-24 -
Patients with Gaucher disease display systemic oxidative stress dependent on therapy status.
Kartha RV, Terluk MR, Brown R, Travis A, et al · · 2020 · cited 16× · PMID 33335836 · DOI 10.1016/j.ymgmr.2020.100667 -
Biological Variation in Peripheral Inflammation and Oxidative Stress Biomarkers in Individuals with Gaucher Disease.
Sahasrabudhe SA, Terluk MR, Rudser KD, Cloyd JC, et al · · 2022 · cited 6× · PMID 36012454 · DOI 10.3390/ijms23169189 -
Secondary Mitochondrial Dysfunction in Gaucher Disease Type I, II and III-Review of the Experimental and Clinical Evidence.
Dewsbury M, Purcell T, Hughes D, Donald A, et al · · 2025 · cited 1× · PMID 41300721 · DOI 10.3390/genes16111269
Verify or expand the search:
- PubMed search for NCT02437396
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Gaucher Disease Type I
Currently open trials in the same condition.
- NCT06162338 — A Study of the Safety and Preliminary Efficacy of LY-M001 Injection in the Treatment of Adult Patients With Gaucher Dise · NA · recruiting
Other University of Minnesota trials
Trials by the same sponsor.
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- NCT04100109 — Evaluating the Metabolic Effects of Polylactose: A Novel Prebiotic · NA · withdrawn
- NCT05454306 — Anser Clavicle Pin for Surgical Management of Midshaft Clavicle Fractures · NA · withdrawn
- NCT03192007 — Multi-Parametric MRI for Renal Transplantation · not yet recruiting
- NCT04940533 — Pharmacokinetics of CFTR Modulators in Pregnant Individuals and in Postpartum Breastfeeding Mothers · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02437396 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Minnesota
- Last refreshed: 16 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02437396.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing