Drug Trials & News

From Staff Reports

Factor IX inhibition in thrombosis prevention (FIXIT) is a phase II study attempting to determine the efficacy of the experimental drug TTP889 in preventing venous thromboembolism following surgery to repair hip fracture. This randomized, placebo-controlled, multicenter trial involves once-daily oral administration of the drug for 3 weeks in patients who have completed standard prophylactic treatment for deep vein thrombosis for 5-9 days after the surgery. The primary end point for the study is the antithrombotic efficacy of TTP889; the secondary end point will assess the correlation between peak and trough plasma concentrations of the drug and efficacy. The study, which is being sponsored by TransTech Pharma, has an expected total enrollment of 300 patients, with the last follow-up anticipated for February 2006. According to the company, TTP889 is the only known selective small molecule inhibitor of factor IX, a key factor in the intrinsic pathway of the blood coagulation system.

Factor Xa inhibition of deep vein thrombosis is a phase II study attempting to determine the safety and efficacy of the experimental drug DU-176b in reducing the occurrence of venous thromboembolism following total hip replacement surgery. This nonrandomized, open-label, multicenter trial involves a dose range study of the once or twice daily oral administration of the drug in adult patients undergoing surgery. The primary end point for the study is the prevention of venous thromboembolism; the secondary end point will assess the safety and tolerability of the drug. The study, which is being sponsored by Daiichi Medical Research, has an expected total enrollment of 402 patients, with an anticipated completion date of September 2005. The drug acts to inhibit factor Xa, a key factor in blood coagulation.

VLTS-934 in subjects with intermittent claudication is a phase II study attempting to determine the efficacy of the experimental drug in patients with peripheral arterial disease. This randomized, placebo-controlled, multicenter trial involves a single treatment of the drug administered as 21 injections (2 mL IM each) bilaterally into the lower extremities. The primary outcome for the study is change in peak walking time with the drug from baseline to day 90, compared with patients receiving a saline placebo. The secondary outcomes will assess changes in total work capacity, ankle-branchial index (ABI), the onset of claudication, and quality of life. The study, which is being sponsored by Valentis, has an expected enrollment of 148 patients, with a completion date of June 2006. According to the company, VLTS-934 is a nonionic block copolymer, known as a poloxamer, that appears to have a direct effect repairing compromised cell membranes and improving cell function, reducing specific mediators of inflammation, an effect believed to account for the improved blood flow seen in the prior clinical trial of VLTS-934.

Alfimeprase to rapidly dissolve blood clots in the leg is a phase III study attempting to compare the safety and efficacy of the thrombolytic drug in preventing the need for surgery on leg arteries. This randomized, placebo-controlled, multinational trial will test the efficacy of 0.3 mg/kg alfimeprase in subjects with acute arterial occlusion. The primary end point for the study is the 30-day open vascular surgery- free rate, with secondary outcomes including rate of arterial flow restoration at 4 hours, and the rate of improvement index limb ABI at 30 days. The study, sponsored by Nuvelo, has an expected enrollment of 300 patients, and began in January 2005.

Rituximab for the treatment of Wegener's granulomatosis and microscopic polyangiitis is a phase II/phase III study to determine efficacy of the engineered antibody in treating patients. This randomized, double-blind, multicenter trial involves comparing rituximab, normally used to treat non-Hodgkins lymphoma, with conventional therapy. The primary outcome for the study is the ability of rituximab to induce complete remission during the first 6 months after randomization. The study, which is being sponsored by the National Institute of Allergy and Infectious Diseases, expects to enroll 200 patients, and began in January 2005.