Ignite Creation Date:
2024-05-06 @ 12:55 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01691040
Status:
COMPLETED
Last Update Posted:
2014-06-26
First Post:
2012-09-04
Brief Title:
Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer
Sponsor:
TME Pharma AG
Organization:
TME Pharma AG
Study Overview
Official Title:
Phase IIa Study to Characterize the Effects of the Spiegelmer NOX H94 on Anemia of Chronic Disease in Patients With Cancer
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
Some chronic diseases eg 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:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-001525-27 | EUDRACT_NUMBER | None | None |