Ensayos clínicos

Inclusion Criteria:

• Adult females 13-45 years of age.
• Mild or moderate von Willebrand disease (VWF:RCo < 0.50 IU/ml, past bleeding.
• Menorrhagia and a PBAC > 100 in at least one of the last two menstrual cycles.
• Regular menses, at least every 21-35 days.
• Willingness to have blood drawn/
• No prior history of an allergic reaction or anaphylaxis to rVWF or TA.
• Willingness to avoid ASA and nonsteroidal anti-inflammatory agents (NSAIDS) during the study.
• Willingness to comply with randomization to rVWF or TA study arms.
• Willingness to keep a personal diary of menorrhagia bleeding frequency duration and severity by pictorial blood assessment chart, and any drugs or hemostatic agents taken.
• Willingness to make 4 visits, undergo blood sampling for coagulation studies, and accept randomization of two therapies for each of four consecutive menstrual cycles, including an end-of-study visit.
• Willingness to use “double-barrier” method of contraception during the study.

Exclusion Criteria:

• Any bleeding disorder other than von Willebrand disease; or past thrombotic disease
• Pregnant or lactating, or use of hormones or oral contraceptives, and contraceptive implants in past 3 months.
• Platelet count < 100,000/ul.
• Use of immunomodulatory or experimental drugs.
• Surgery within the past 8 weeks.
• Concomitant use of antiplatelet drugs, anticoagulants, dextran, aspirin or NSAIDs.
• Treatment with DDAVP, cryoprecipitate, whole blood, plasma and plasma derivatives containing VWF within 5 days of study.
• Inability to comply with study requirements.
• Hypothyroidism as defined by elevated TSH.
• Iron deficiency as defined by low serum ferritin, unless iron replacement has been initiated.
• History of renal disease.