NCT01691040

Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer

Phase IIa Study to Characterize the Effects of the Spiegelmer® NOX H94 on Anemia of Chronic Disease in Patients With Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: TME Pharma AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia of Chronic Disease

Interventions

Type	Name	Description
DRUG	NOX-H94	intravenous injection
DRUG	Placebo solution	intravenous injection

Timeline

• Start date: 2012-09-01
• Primary completion: 2013-11-01
• Completion: 2013-12-01
• First posted: 2012-09-24
• Last updated: 2014-06-26

Locations

11 sites across 3 countries: Austria, Bulgaria, Romania