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Von Willebrand Diseases clinical trials

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NCT ID: NCT01261936 Recruiting - Clinical trials for Von Willebrand Disease

Evaluation of Menses in Congenital Bleeding Disorders

MEVA-3
Start date: February 2010
Phase: N/A
Study type: Observational

Menorrhagia is the term used to define excessive menstrual blood losses, as often based on a subjective judgment of women. Many arbitrary values, expressed in milliliters of blood, have been proposed to define this symptom: 60 on each cycle has also been confirmed in our preliminary study on 87 healthy women. The quantitative determination of menstrual blood losses is nevertheless rarely performed, only in research settings. Although menorrhagia is a quite frequent symptom in healthy women apparently haemostatically competent in the fertile age (20-30%), its incidence becomes very high in women affected by congenital coagulation factors deficiency and (50-62.9%) inherited platelet defects, e.g. Glanzmann's Thromboasthenia (GT); also in von Willebrand Disease the bleeding symptom "menorrhagia" has an high prevalence (60-75%)(8); for GT an incidence of 90% has been reported. This explains the need for a study focused on the evaluation of menorrhagia in CBDs, addressed to answer to the following, still unsolved questions: 1. Definition of the entity of menstrual blood losses in women affected by CBDs 2. Elaboration of specific treatment schedules for each type of CBD 3. Impact of different specific treatment schedules on kinetic and entity of menstrual losses (how does treatment modify losses?).

NCT ID: NCT01224808 Completed - Clinical trials for Von Willebrand Disease

Extension Study of Biostate in Subjects With Von Willebrand Disease

Start date: October 2010
Phase: Phase 3
Study type: Interventional

The aim of the Von Willebrand Disease (VWD) therapy is to treat and prevent bleeding episodes due to abnormal platelet adhesion and abnormal blood coagulation as a result of low or abnormal Von Willebrand Factor (VWF) and/or Factor VIII (FVIII) levels. The long-term efficacy and safety of a VWF/FVIII concentrate, Biostate, will be investigated in children, adolescents, and adults with VWD in whom treatment with a VWF product is required for prophylactic therapy, haemostatic control during surgery, or control of a non-surgical, spontaneous, or traumatic bleeding event.

NCT ID: NCT01213446 Completed - Clinical trials for Von Willebrand Disease

Study of Biostate® in Children With Von Willebrand Disease

Start date: August 2010
Phase: Phase 3
Study type: Interventional

This is an open-label study to investigate the pharmacokinetics (PK), efficacy, and safety of a von Willebrand Factor/Factor VIII (VWF/FVIII), Biostate, in children with Von Willebrand disease (VWD) in whom treatment with a VWF product is required for prophylactic therapy, haemostatic control during surgery, or control of a non-surgical, spontaneous, or traumatic bleeding event.

NCT ID: NCT00994929 Completed - Hemophilia A Clinical Trials

Efficacy and Safety of IL-11 in DDAVP Unresponsive

IL-11DDAVP
Start date: January 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the biologic efficacy and safety of rhIL-11 when given subcutaneously in adults with moderate or mild hemophilia A or Von Willebrand disease unresponsive to DDAVP. Biologic efficacy will be measured by the number and percent increase of VWD coagulation tests (FVIII:C, VWF: Ag, VWF: RCo, closure time, APTT, and VWF multimers) to the normal range, or at least to 1.5-3 time baseline, following dosing of rhIL-11 when given daily for 4 days, and boosted by DDAVP infusion on day 4, in those in whom DDAVP is not contraindicated. Safety will be measured by the frequency of adverse events, including fever, headache, fatigue, myalgias, arthralgias, fluid retention, or edema.

NCT ID: NCT00941616 Completed - Clinical trials for Von Willebrand Disease

Study of a pd VWF/FVIII Concentrate, Biostate®, in Subjects With Von Willebrand Disease

Start date: June 2009
Phase: Phase 2/Phase 3
Study type: Interventional

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.

NCT ID: NCT00816660 Completed - Clinical trials for Von Willebrand Disease

Pharmacokinetic, Safety and Tolerability Study of Recombinant Von Willebrand Factor / Recombinant Factor VIII Complex in Type 3 Von Willebrand Disease

Start date: December 1, 2008
Phase: Phase 1
Study type: Interventional

The objectives of this study are to evaluate the immediate tolerability and safety of rVWF:rFVIII in subjects with Type 3 Von Willebrand Disease after administration of various dosages of VWF:RCo.

NCT ID: NCT00805051 Completed - Bleeding Clinical Trials

Acquired Von Willebrand Syndrome in Severe Aortic Stenosis

Start date: October 2008
Phase: N/A
Study type: Observational

Patients with severe aortic stenosis often suffer from an acquired Von Willebrand syndrome by degeneration of the polymers during passage through the narrow valve leading to turbulences. We hypothesized that the diagnosis of acquired von Willebrand syndrome influence perioperative blood loss in patients undergoing open cardiac valve replacement.

NCT ID: NCT00701545 Completed - Clinical trials for Von Willebrand Disease

A Canadian Study to Assess the Safety of Humate-P® Ivr (Infusion Volume Reduced)

Start date: February 2008
Phase: N/A
Study type: Observational

As part of CSL Behring Canada's continued commitment to ensuring the safety of the new low volume preparation of Humate-P®, CSL Behring Canada proposes to conduct a prospective, multi-center structured data collection of routine management of patients with von Willebrand disease treated with Humate P® ivr in Canada. The surveillance will be non-interventional and non-experimental. During the observation period, the routine medical care of the patient will be documented. It is expected that there will be no difference in the safety and tolerability of Humate-P® ivr compared to Humate-P®

NCT ID: NCT00697385 Completed - Hemophilia Clinical Trials

The Use of Cyclokapron for Treatment and Management of Women With Bleeding Disorders

Start date: April 2003
Phase: N/A
Study type: Interventional

The high percentage of failure using available non-surgical options to treat menorrhagia in women with bleeding disorders shows a continuing need for innovative treatments. This has led to development of this protocol in order to make available tranexamic acid as a potentially effective menorrhagia therapy option in women with an underlying bleeding disorder. We anticipate that Tranexamic Acid may be a beneficial choice for controlling menorrhagia in bleeding disorder patients.

NCT ID: NCT00694785 Withdrawn - Clinical trials for Von Willebrand Disease

A Study of the Pharmacokinetics, Pharmacodynamics, and Safety of ARC1779 Injection in Patients With Von Willebrand Disease Type 2B

Start date: October 2008
Phase: Phase 2
Study type: Interventional

To evaluate the effect of ARC1779, a therapeutic oligonucleotide ("aptamer") in patients with Type2B von Willebrand Disease.