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NCT04053699 · ClinicalTrials.gov registry record
Bleeding Incidence in VWD Patients Undergoing On-Demand Treatment
A clinical trial of Von Willebrand Diseases, sponsored by Octapharma.
- Completed
- Registry status
- 56
- Enrollment target
- 15
- Study locations
NCT04053699: Completed study of Von Willebrand Diseases, sponsored by Octapharma.
NCT04053699 is a study of Von Willebrand Diseases that has completed, run by Octapharma. The registered enrollment target is 56 participants, below the 727-participant average among 5 other Von Willebrand Diseases trials with a reported enrollment target (92% lower). The trial reports 15 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04053699, a study of Von Willebrand Diseases, has completed, sponsored by Octapharma.
- COMPLETED
- Registry status
- 56 participants
- Enrollment target
- 15
- Study locations
Study 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 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.
Primary Outcome
The total annualized bleeding rate (TABR) will be calculated as the total number of spontaneous bleeds, traumatic BEs, and other BEs occurring in the time period between the start of data collection for each patient and the Study Completion Visit, divided by the duration (in years) between the start of data collection and the Study Completion Visit. Surgery periods, and BEs occurring within these surgery periods, will be excluded from the calculation of TABR.
Conditions Studied
Interventions
- DRUG Von Willebrand Factor-Containing Product
Study Locations (15)
Other
- Republican Research Center for Radiation Medicine and Human Ecology - Homyel
- Specialized Hospital for Active Treatment of Haematological Diseases" EAD, Sofia - Sofia
- "UMHAT Sveta Marina" EAD. - Varna
- University Hospital Centre Zagreb - Zagreb
- Medical Centre Hungarian Defence Forces - Budapest
- Debreceni Egyetem Klinikai Központ, Regionális Haemophilia és Thrombophilia Központ - Debrecen
- University Clinical Center, Department of Internal Medicine, Hematology - Pécs
- Hotel Dieu de France Hospital - Beirut
- American University of Beirut Medical Center - Beirut
- Nini Hospital - Tripoli
- Federal State Budgetary Scientific Institution Kirov Scientific-Research Institute of Hematology and Blood Transfusion of Federal - Kirov
- Morosovskaya Children Clinical Hospital, Moscow Health Department, Department of General Hematology with the Pathology of Hemostasis - Moscow
- State Institution "National Children's Specialized Hospital "OKHMATDYT" of the Ministry of Health of Ukraine," Center of Hemostasis Pathology - Kyiv
- Community Institution of Lviv Oblast Council "West-Ukrainian Specialized Children's Medical Center - Lviv
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2019-06-25 |
| Est. Completion | 2021-01-31 |
What the finished NCT04053699 record still lists
NCT04053699 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 727-participant average among 5 other Von Willebrand Diseases trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Von Willebrand Diseases appearing as the primary indexed condition, and to 1 intervention - of which Von Willebrand Factor-Containing Product is the first listed.
NCT04053699 lists 15 locations in 2 states (Other, Georgia).
Frequently Asked Questions
What is clinical trial NCT04053699 about?
NCT04053699 is a clinical study titled "Bleeding Incidence in VWD Patients 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...
What is the current status of trial NCT04053699?
This trial is currently completed. The enrollment target is 56 participants. The study started on 2019-06-25. Estimated completion is 2021-01-31.
What conditions does trial NCT04053699 study?
This clinical trial studies the following conditions: Von Willebrand Diseases.
What interventions are being tested in trial NCT04053699?
The interventions under investigation include: Von Willebrand Factor-Containing Product (DRUG).
Who is sponsoring clinical trial NCT04053699?
This trial is sponsored by Octapharma, which has 43 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04053699 being conducted?
This trial has 15 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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