B1831077 moderately severe or severe haemophilia

• Research type

  Research Study

• Full title

  An Open-label, Randomized, Two Period Crossover Study to Compare Relative Bioavaioabiloity of Two Presentations of Moroctocog alfa (AF-CC) in Subjects with Moderately Severe or Severe Hemophilia A

• IRAS ID

  99984

• Contact name

  Pratima Chowdary

• Sponsor organisation

  Pfizer Inc, 235 East 42nd Street, New York, NY 10017, USA

• Eudract number

  2011-004861-34

• ISRCTN Number

  n/a

• Research summary

  This is a Phase 1 study, testing a study drug in a small group of people to evaluate how the study drug acts in the body and to evaluate the safety of the study drug. Phase 1 study participants are typically healthy individuals, although for some studies participants are patients with the disease that the drug is intended to treat. This Phase 1 study will be conducted in patients with haemophilia A, a disease which is caused when the body cannot produce enough of a substance called Factor VIII which is needed by the body to clot blood and stop bleeding. Patients with moderately severe or severe haemophilia are being asked to take part in this study to compare two different dose preparations of ReFacto AF© to see how the body deals with the drug.

• REC name

  London - Hampstead Research Ethics Committee

• REC reference

  12/LO/0416

• Date of REC Opinion

  5 Apr 2012

• REC opinion

  Favourable Opinion