Status:
COMPLETED
Bleeding Incidence in VWD Patients Undergoing On-Demand Treatment
Lead Sponsor:
Octapharma
Conditions:
Von Willebrand Diseases
Eligibility:
All Genders
66+ years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 25 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 31 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04053699
Start Date
June 25 2019
End Date
January 31 2021
Last Update
December 7 2023
Active Locations (15)
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1
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
2
Republican Research Center for Radiation Medicine and Human Ecology
Homyel, Belarus
3
Specialized Hospital for Active Treatment of Haematological Diseases" EAD, Sofia
Sofia, Bulgaria
4
"UMHAT Sveta Marina" EAD.
Varna, Bulgaria, 9010