Study of Voncento® in Subjects With Von Willebrand Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-05

Study Completion Date

2018-02-15

Brief Summary

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This is a multi-centre, open-label, single-arm, phase 4, post-marketing study to further investigate the efficacy and safety of Voncento in subjects with Von Willebrand Disease (VWD) in whom treatment with a Von Willebrand Factor (VWF) product is required as on-demand therapy, for prophylactic therapy, or during surgery. Subjects will be treated with Voncento either as an on-demand regimen (eg, to treat a non-surgical spontaneous or traumatic bleeding event) or prevention regimen (eg, to prevent an anticipated bleeding event) at a dose prescribed by the Investigator in accordance with the Voncento Summary of Product Characteristics (SmPC), or with a prophylaxis regimen (regular treatment with Voncento at a frequency of 1-3 times per week). Voncento will also be given to prevent and treat any surgical bleeding events.

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Detailed Description

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Conditions

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Von Willebrand Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Voncento

The frequency and dose of Voncento administration will be determined by the investigator using the information included in the Voncento Summary of product characteristics (SmPC)

Group Type EXPERIMENTAL

Voncento

Intervention Type BIOLOGICAL

Human coagulation VWF / coagulation factor VIII (FVIII) complex concentrate

Interventions

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Voncento

Human coagulation VWF / coagulation factor VIII (FVIII) complex concentrate

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of severe type 1, 2A, or 3 VWD where Von Willebrand Factor: Ristocetin Cofactor (VWF:RCo) is \<20% at screening
* Desmopressin acetate treatment is ineffective, contraindicated, or not available for subject (type 3 VWD subjects only).
* Evidence of vaccination against hepatitis A and B or presence of antibodies against hepatitis A and B due to either a previous infection or prior immunization.
* Written informed consent given.
* Require a VWF product to control a non-surgical bleeding (NSB) event or for ongoing prophylactic therapy.

Exclusion Criteria

* Known history or suspicion of having VWF or FVIII inhibitors
* Acute or chronic medical condition, other than VWD, which may affect the conduct of the study
* Known or suspected hypersensitivity or previous evidence of severe side effects to Voncento, VWF / FVIII concentrates, or human albumin.
* Participated in another interventional clinical study within 30 days before the first administration of Voncento or at any time during the study.
* Females who are pregnant, breast-feeding or who have a positive pregnancy test at screening
* Alcohol, drug, or medication abuse within 1 year before the study.
* Currently receiving a therapy not permitted during the study.
* Previous participation in a Voncento / Biostate study.

Eligible Sex

ALL

Accepts Healthy Volunteers

No