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NOX-H94

Placebo solution

Kai Riecke, MD

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.

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

• Hb increase ≥1 g/dL OR reticulocyte index normalization (≥1%) at any time point until 1 week after the end of treatment

AND absence of all of the following treatment failure criteria until 1 week after the end of treatment:

* Erythrocyte transfusion, ESA or IV iron,
* Hb drop by ≥1 g/dL
* Treatment interruption due to adverse events (AEs)

Proportion of treatment responders at study visits V4, V6, V8, and V10 to V14, as defined for the primary efficacy endpoint

Proportion of treatment failures at study visits V4, V6, V8, and V10, as defined for the primary efficacy endpoint

Adverse events, Safety signals derived from laboratory diagnostics, vital signs.

Absolute concentrations and change from baseline

TME Pharma AG

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer	NCT01691040	Anemia of Chron...	NOX-H94 Placebo solutio...	18 Years -	TME Pharma AG
Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer	NCT01691040	Anemia of Chron...	NOX-H94 Placebo solutio...	18 Years -	TME Pharma AG

Spots Global Cancer Trial Database for iron restriction