Clinical Trials Logo

Clinical Trial Summary

The purpose of this study is to assess the effect of the anti-hepcidin Spiegelmer NOX-H94 on iron homeostasis during systemic inflammation induced by endotoxin.

In the human endotoxemia model, intravenously administered lipopolysaccharide elicits an inflammatory response with release of pro-inflammatory cytokines, such as IL-6 and TNF-alfa, with subsequent induction of hepcidin. As a consequence of hepcidin induction, serum iron concentrations decrease.

This study in healthy subjects investigates the capacity of NOX-H94 to inactivate hepcidin and to prevent serum iron decrease in a pathophysiological model prior to studying the efficacy of NOX-H94 in patients with anemia of chronic disease.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01522794
Study type Interventional
Source NOXXON Pharma AG
Contact
Status Completed
Phase Phase 1
Start date January 2012
Completion date April 2012

See also
  Status Clinical Trial Phase
Recruiting NCT05217836 - Iron Metabolism Disorders in Patients With Sepsis or Septic Shock.
Completed NCT01691040 - Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer Phase 2
Completed NCT01988116 - Effects of Vitamin D Replacement on Hormones Regulating Iron Metabolism in Individuals With Chronic Kidney Disease Phase 0
Terminated NCT01873534 - A Phase 2A Trial of FMX-8 Treatment for Anemia in Patients With ESRD on Hemodialysis HD Phase 2
Not yet recruiting NCT01846689 - An Open-label Trial to Determine Increased Red Blood Cell Production in Subjects With Anemia of Chronic Disease Phase 3
Terminated NCT03528564 - Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia Phase 2
Not yet recruiting NCT04071067 - Anemia of Inflammation and Deficiency Anemia