Von Willebrand Disease Clinical Trial
Official title:
An Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy and Safety of Biostate® in Subjects With Von Willebrand Disease.
The aim of this study is to assess the pharmacokinetics (PK), efficacy, and safety of
Biostate® in subjects with Von Willebrand Disease (VWD).
Pharmacokinetic Component:
PK parameters will be determined from a subgroup of subjects. Subjects who complete the PK
component will subsequently continue in the efficacy component of the study, either
continuing on a previously established prophylaxis regimen or continuing to receive on-demand
treatment with the occurrence of non-surgical bleeding (NSB) events.
Efficacy Component:
Three treatment arms are defined for the efficacy component of the study. (1) Subjects who
are currently being treated on a set prophylaxis regimen with a VWF product at the time of
study entry will be enrolled in the "Prophylaxis" arm. (2) Subjects not being treated on a
set prophylaxis regimen at the time of study entry who require a VWF product for the
treatment of NSB events will be enrolled in the "On-demand" arm and commence using Biostate
in the treatment of NSB events. (3) Subjects enrolled in the "On-demand" arm have the
possibility to enter the "Cross-over to Prophylaxis" arm to receive an additional 12 months
of prophylactic treatment.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT01651468 -
The Effect of the Nutraceutical "Hemofix" on the Coagulation System
|
N/A | |
| Active, not recruiting |
NCT00555555 -
Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients
|
Phase 4 | |
| Terminated |
NCT00178542 -
Change in Thrombin Generation Potential and Thromboelastography During the Menstrual Cycle
|
N/A | |
| Completed |
NCT02552576 -
Study of Voncento® in Subjects With Von Willebrand Disease
|
Phase 4 | |
| Recruiting |
NCT02869074 -
Molecular and Clinical Profile of Von Willebrand Disease in Spain
|
||
| Completed |
NCT01602419 -
Surveillance of Safety and Efficacy of Wilate in Patients With Von Willebrand Disease
|
||
| Completed |
NCT01224808 -
Extension Study of Biostate in Subjects With Von Willebrand Disease
|
Phase 3 | |
| Withdrawn |
NCT00694785 -
A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2B
|
Phase 2 | |
| Completed |
NCT00805051 -
Acquired Von Willebrand Syndrome in Severe Aortic Stenosis
|
N/A | |
| Completed |
NCT00168090 -
Study of Safety and Efficacy of Antihemophilic Factor/Von Willebrand Factor Complex in Surgical Subjects With Von Willebrand Disease (vWD)
|
Phase 4 | |
| Completed |
NCT02246881 -
A Study to Compare the Pharmacokinetics and Safety of Current Factor VIII Concentrate and Optivate® in Haemophilia A.
|
Phase 3 | |
| Completed |
NCT04657887 -
Registry of Patients With Von WilLEbrand Disease Treated With Voncento®
|
||
| Withdrawn |
NCT00630448 -
Collection of Blood in Normal Subjects and Subjects With Von Willebrand Disease (VWD)
|
N/A | |
| Terminated |
NCT00387192 -
A Study With OPTIVATE® in People With Von Willebrand Disease
|
Phase 3 | |
| Completed |
NCT02973087 -
rVWF IN PROPHYLAXIS
|
Phase 3 | |
| Completed |
NCT01410227 -
Pharmacokinetics, Safety and Efficacy of Recombinant Von Willebrand Factor (rVWF) in the Treatment of Bleeding Episodes in Von Willebrand Disease (VWD)
|
Phase 3 | |
| Completed |
NCT01949220 -
Willebrand International Non-interventional Global Surveillance
|
||
| Completed |
NCT01589848 -
Study on Von Willebrand Disease and Hemophilia in Cuenca, Ecuador
|
N/A | |
| Completed |
NCT00557908 -
The Von Willebrand Disease (VWD) International Prophylaxis Study
|
N/A | |
| Active, not recruiting |
NCT04953884 -
Efficacy, PK, Immunogenicity and Safety of Wilate in Severe Von Willebrand Disease VWD) Patients <6 Years of Age
|
Phase 3 |