Bleeding Incidence in VWD Patients Undergoing On-Demand Treatment

A Prospective, Multicenter, Non-Interventional Study Evaluating the Bleeding Incidence in Patients With Von Willebrand Disease Undergoing On-Demand Treatment

The purpose of this study is to prospectively obtain reliable data on the bleeding and treatment pattern of patients with VWD undergoing on-demand treatment with a VWF-containing product over a period of 6 months. The data obtained will be used as a basis for historical comparisons with the bleeding and treatment pattern obtained from a clinical study on the efficacy of prophylactic treatment with a VWF/FVIII concentrate.

Inclusion Criteria:

Patients who meet all of the following criteria are eligible for the study:

• Male or female patients aged ≥5.5 years at the time of enrolment
• VWD type 1 (baseline von Willebrand factor activity [VWF:RCo], <30 IU/dL), 2A, 2B, 2M, or 3 according to medical history requiring substitution therapy with a VWF-containing product to control bleeding
• Currently receiving frequent on-demand treatment with a VWF-containing product
• In female patients of child-bearing potential using hormonal contraception, the medication class should remain unchanged for the duration of their study participation
• Voluntarily given, fully informed written and signed consent obtained before collection of any patient data

Exclusion Criteria:

Patients who meet any of the following criteria are not eligible for the study:

• Patients currently on prophylaxis for VWD (except for perioperative prophylaxis) as well as patients having received treatment once a month for menstrual bleeding, but not for any other bleeds
• Patients whose VWD treatment is planned to be switched from on-demand to prophylactic treatment in the next 6 months
• History, or current suspicion, of VWF or FVIII inhibitors
• Medical history of a thromboembolic event within 6 months before enrolment
• Severe liver or kidney diseases as described in the medical records
• Female patients with an existing or suspected pregnancy or who are breast-feeding at the time of enrolment
• Change in hormonal contraception within 6 months before enrolment
• Cervical or uterine conditions causing abnormal uterine bleeding (including infection or dysplasia)
• Other coagulation disorders or bleeding disorders due to anatomical reasons
• Participation in an interventional clinical study during the 6-month of study period
• Inability to complete the patient diary to reliably evaluate the type, frequency, and treatment of BEs during the 6-month study period