The phase III trial is one of two overlapping multi-national trials in Nuvelo’s phase III alfimeprase program for catheter occlusion.
The first study compares the efficacy of 3mg of alfimeprase with placebo in 300 patients with occluded central venous catheters. Two-thirds of the participants will receive alfimeprase and the remainder will receive placebo. The primary endpoint of the study is restoration of catheter function within 15 minutes.
The second study in the phase III program will evaluate the safety and efficacy of alfimeprase in 800 patients.
Illustrating the need for catheter occlusion treatments, Dr Peter Kenyon, hematologist at The Corvallis Clinic, stated: “Each year in the US, approximately five million catheters are placed in patients to deliver chemotherapy, nutritional support, antibiotics and blood products. One-quarter of these catheters becomes occluded, inhibiting the flow of medications and presenting a significant risk to patients.”