NCT02239146 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Levy JH, Gill R, Nussmeier NA, Olsen PS, Andersen HF, Booth FV, Jespersen CM
Repletion of factor XIII following cardiopulmonary bypass using a recombinant A-subunit homodimer. A preliminary report. Thromb Haemost. 2009 Oct;102(4):765-71. doi: 10.1160/TH0

A Multi-Centre, Randomised, Double-Blind, Placebo Controlled, Dose Escalation Trial on Safety and Pharmacokinetics of Recombinant Factor XIII (rFXIII) in Patients Following First Time Myocardial Revascularization Requiring Cardiopulmonary Bypass

Details for clinical trial NCT02239146

Clinical trial NCT02239146 - References