Spots Global Cancer Trial Database for Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer
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Trial Identification
Brief Title: Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer
Official Title: Phase IIa Study to Characterize the Effects of the Spiegelmer® NOX H94 on Anemia of Chronic Disease in Patients With Cancer
Study ID: NCT01691040
Conditions
Study Description
Brief 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.
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Hospital, Graz, , Austria
AKH Vienna, Vienna, , Austria
Wilhelminenspital, Vienna, , Austria
University Hospital, Plovdiv, , Bulgaria
Tokuda Hospital, Sofia, , Bulgaria
University Hospital, Varna, , Bulgaria
Spitalul Judetean, Brasov, , Romania
Institutul Oncologic, Cluj-Napoca, , Romania
Spitalul Municipal, Craiova, , Romania
Spitalul Judetean, Targu-Mures, , Romania
Oncomed, Timisoara, , Romania
Contact Details
Name: Kai Riecke, MD
Affiliation: TME Pharma AG
Role: STUDY_DIRECTOR
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