NCT00633659 - 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)

Björkholm M, Fagrell B, Przybelski R, Winslow N, Young M, Winslow RM
A phase I single blind clinical trial of a new oxygen transport agent (MP4), human hemoglobin modified with maleimide-activated polyethylene glycol. Haematologica. 2005 Apr;90(4):505-15.
Olofsson C, Ahl T, Johansson T, Larsson S, Nellgård P, Ponzer S, Fagrell B, Przybelski R, Keipert P, Winslow N, Winslow RM
A multicenter clinical study of the safety and activity of maleimide-polyethylene glycol-modified Hemoglobin (Hemospan) in patients undergoing major orthopedic surgery. Anesthesiology. 2006 Dec;105(6):1153-63.
Olofsson C, Nygårds EB, Ponzer S, Fagrell B, Przybelski R, Keipert PE, Winslow N, Winslow RM
A randomized, single-blind, increasing dose safety trial of an oxygen-carrying plasma expander (Hemospan) administered to orthopaedic surgery patients with spinal anaesthesia. Transfus Med. 2008 Feb;18(1):28-39. doi: 10.1111/j.1365-3148.2007.00811.x.
Winslow RM
Red cell substitutes. Semin Hematol. 2007 Jan;44(1):51-9. Review.

A Phase II Study of Hemospan® Versus Voluven® to Evaluate Vascular Resistance and Forearm Blood Flow, and to Assess Local Skin Blood Flow and Tissue Oxygenation in the Ischemic Foot of Patients With Chronic Critical Limb Ischemia

Details for clinical trial NCT00633659

Clinical trial NCT00633659 - References