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Clinical Trial Summary

This study is conducted to determine the safety, tolerability, and efficacy of NOX-H94 in patients with anemia of chronic disease (ACD). Furthermore, this study is intended to provide data needed to correlate plasma concentrations of NOX-H94 with its efficacy and to choose the appropriate dose and dose schedule of subsequent efficacy studies.

Some chronic diseases, e.g. tumors, inflammation, renal disease, are associated with high hepcidin concentrations in the blood. These hepcidin concentrations cause a reduction in iron concentrations in the blood and subsequently impair formation of red blood cells. Treatment with NOX-H94 is expected to inhibit this patho-mechanism by binding and inactivating hepcidin.


Clinical Trial Description

n/a


Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01691040
Study type Interventional
Source NOXXON Pharma AG
Contact
Status Completed
Phase Phase 2
Start date September 2012
Completion date December 2013

See also
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Terminated NCT01873534 - A Phase 2A Trial of FMX-8 Treatment for Anemia in Patients With ESRD on Hemodialysis HD Phase 2
Terminated NCT03528564 - Hemoglobin Optimization to Prevent Transfusion and Adverse Events in Perioperative Patients With Iron Restricted Anemia Phase 2
Completed NCT01522794 - Pharmacokinetics/Pharmacodynamics of NOX-H94 in the Human Endotoxemia Model Phase 1
Not yet recruiting NCT04071067 - Anemia of Inflammation and Deficiency Anemia