Bleeding Incidence in VWD Patients Undergoing On-Demand Treatment
Completed
Conditions studied: Von Willebrand Diseases
In brief
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.
Key facts
- Study ID
- NCT04053699
- Run by
- Octapharma
- People needed
- 56
- Starts
- 2019-06-25
- Expected to finish
- 2021-01-31
- Last updated by the study team
- 2023-12-07
Who can join
Age: 6 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States
- Republican Research Center for Radiation Medicine and Human Ecology — Homyel, Belarus
- Specialized Hospital for Active Treatment of Haematological Diseases" EAD, Sofia — Sofia, Bulgaria
- "UMHAT Sveta Marina" EAD. — Varna, Bulgaria
- University Hospital Centre Zagreb — Zagreb, Croatia
- Medical Centre Hungarian Defence Forces — Budapest, Hungary
- Debreceni Egyetem Klinikai Központ, Regionális Haemophilia és Thrombophilia Központ — Debrecen, Hungary
- University Clinical Center, Department of Internal Medicine, Hematology — Pécs, Hungary
- Hotel Dieu de France Hospital — Beirut, Lebanon
- American University of Beirut Medical Center — Beirut, Lebanon
- Nini Hospital — Tripoli, Lebanon
- Federal State Budgetary Scientific Institution Kirov Scientific-Research Institute of Hematology and Blood Transfusion of Federal — Kirov, Russia
- Morosovskaya Children Clinical Hospital, Moscow Health Department, Department of General Hematology with the Pathology of Hemostasis — Moscow, Russia
- State Institution "National Children's Specialized Hospital "OKHMATDYT" of the Ministry of Health of Ukraine," Center of Hemostasis Pathology — Kyiv, Ukraine
- Community Institution of Lviv Oblast Council "West-Ukrainian Specialized Children's Medical Center — Lviv, Ukraine
Full record on ClinicalTrials.gov
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