// App-Quantinova.ai

P390 : Open-label study to evaluate the pharmacokinetics of fidaxomicin in inflammatory bowel disease patients with Clostridium difficile infection (the PROFILE study): pharmacokinetics analysis

Researchers

Presenter

  • C. Hgenauer

Principal Investigators

  • Y. Mahida

  • A. Stallmach

  • P. Marteau

  • G. Rydzewska

  • V. Ivashkin

  • P. Gargalianos-Kakolyris

  • I. Michon

  • N. Adomakoh

  • W. Reinisch

Medical Centers

  • Medical University Graz, Graz, Austria

  • University of Nottingham, Nottingham, United Kingdom

  • Essen University Hospital, Essen, Germany

  • Hospital Saint Antoine, Paris, France

  • Central Clinical Hospital of the Ministry of the Interior, Warsaw and Jan Kochanowski University, Kielce, Poland

  • 'First Moscow State Medical University named after I.M. Sechenov' of the Ministry of Health of Russian Federation, Moscow, Russian Federation

  • General Hospital of Athens ‘Georgios GennimatasÂ’, Athens, Greece

  • Astellas Pharma Europe, Leiden, Netherlands

  • Astellas Pharma Inc., Chertsey, United Kingdom

  • Medical University of Vienna, Vienna, Austria

Locations

  • Austria

  • United Kingdom

  • Germany

  • France

  • Poland

  • Russia

  • Greece

  • Netherlands

Companies

  • N/A

Study Components

Therapeutic Area

  • Gastroenterology (GU)

  • Infectious Diseases (ID)

  • Genetic Disorder

Disease

  • N/A

Biomarkers

  • N/A

Drug/Treatment

  • Fidaxomicin

Outcome

  • N/A


Study Design

  • Pharmacokinetics

  • Open Label

  • Single Arm

  • Multicenteric

Phase

  • III

Study Id's

  • N/A

Sponsors

  • N/A

Result

  • N/A