NCT01372137|CompletedPhase 1
Loading search results
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
interventional
64
1 country
1
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)This is the first clinical trial with NOX-H94. The purpose of this clinical trial is to identify a safe and efficacious treatment regimen for the clinical development of NOX-H94 in patients with anemia of chronic disease (inflammation).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2012
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 8, 2011
Actual (reported)June 13, 2011
Actual (reported)July 2011
Date type not reportedThis date has not been verified as actual or estimated.
March 2012
Actual (reported)March 2012
Actual (reported)Incidence of adverse events
0 to 90 days
drug plasma concentrations
0 to 29 days
Group A: single 15 minutes IV infusion of 0.3 mg/kg NOX-H94 Group B: single 15 minutes IV infusion of 0.6 mg/kg NOX-H94 Group C: single 15 minutes IV infusion of 1.2 mg/kg NOX-H94 Group D: single 15 minutes IV infusion of 2.4 mg/kg NOX-H94 Group E: single 15 minutes IV infusion of 4.8 mg/kg NOX-H94 Group F: single / repeated SC injection of NOX-H94 over a treatment period of 2 weeks Group G: multiple doses of NOX-H94 as a 15 minutes IV infusion over a treatment period of 2 weeks Group H: multiple doses of NOX-H94 as a 15 minutes IV infusion over a treatment period of 2 weeks
Group A to Group H get NOX-H94 or Placebo
Dosage form: NOX-H94 25 mg (oligonucleotide basis) Solution for Injection Strength: 14.6 mg NOX-H94 / mL Dose: 0.3 - 4.8 mg/kg single dose Route: IV infusion over 15 minutes / SC administration
Placebo
HMR
London, NW10 7EW, United Kingdom
Park EJ, Choi J, Lee KC, Na DH. Emerging PEGylated non-biologic drugs. Expert Opin Emerg Drugs. 2019 Jun;24(2):107-119. doi: 10.1080/14728214.2019.1604684. Epub 2019 Apr 19.
Riecke Kai, MD
TME Pharma AG
64 participants (actual enrollment reported by the registry).
First Submitted
June 8, 2011
First Posted
June 13, 2011
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Efficacy of NOX-H94 on Anemia of Chronic Disease in Patients With Cancer
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 2012
Actual (reported)Study Completion
March 2012
Actual (reported)Last Updated
January 25, 2016
Record last verified: 2014-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: