NCT01601457 - 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)

Hsia CC, Chin-Yee IH, McAlister VC
Use of recombinant activated factor VII in patients without hemophilia: a meta-analysis of randomized control trials. Ann Surg. 2008 Jul;248(1):61-8. doi: 10.1097/SLA.0b013e318176c4ec.
Raobaikady R, Redman J, Ball JA, Maloney G, Grounds RM
Use of activated recombinant coagulation factor VII in patients undergoing reconstruction surgery for traumatic fracture of pelvis or pelvis and acetabulum: a double-blind, randomized, placebo-contro

A Single-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Efficacy and Safety of Activated Recombinant Coagulation Factor VII (rFVIIa, NovoSeven®) in Patients With Major Fractures of Pelvis or Pelvis and Acetabulum Undergoing Repair Surgery

Details for clinical trial NCT01601457

Clinical trial NCT01601457 - References