An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease

CSL Behring GmbH0 sites30 target enrollmentAugust 19, 2015

Overview

No summary available.

Registry

who.int

Start Date

August 19, 2015

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Subjects meeting all of the following inclusion criteria may be enrolled into the study:
•1\. Capable of providing written informed consent and willing and able to adhere to all protocol requirements, or the subject’s parent(s) or legally acceptable representative(s) is / are capable of providing written informed consent.
•2\. Male or female.
•3\. At least 12 years of age at the time of providing written informed consent. Subjects aged \<12 years are only allowed to enter once the results from paediatric study CSLCT\-BIO\-08\-52 are considered positive by the EMA.
•4\. Diagnosis of severe type 1, 2A, or 3 VWD where VWF:RCo is \<20% at screening.
•5\. Availability of detailed patient documentation (eg, medical record, diary, logbook) covering prior bleeding and VWD treatment history over the past 12 months prior to screening.
•6\. Subjects where DDAVP treatment is ineffective or contraindicated. In countries where DDAVP is not available only subjects with type 3 VWD are allowed to be enrolled.
•7\. A documented vaccination against hepatitis A and B in the subject’s medical record (or presence of antibodies against hepatitis A and B due to either a previous infection or vaccination) prior to the first dose of Voncento.
•8\. Investigator believes that the subject or the subject’s parent(s) or legally acceptable representative(s) is / are willing and able to adhere to all protocol requirements.
•Are the trial subjects under 18? yes

•Subjects meeting any of the following exclusion criteria must not be enrolled into the study:
•1\. A known history of VWF or FVIII inhibitors, or are suspected to have VWF or FVIII inhibitors.
•2\. Suffering any acute or chronic medical condition, other than VWD, which may, in the opinion of the investigator, affect the conduct of the study.
•3\. Known or suspected hypersensitivity or previous evidence of severe side effects to Voncento, VWF / FVIII concentrates, or human albumin.
•4\. Participated in another interventional clinical study within 30 days before the first administration of Voncento or at any time during the study.
•5\. Female subjects who are pregnant, breast\-feeding, or who have a positive pregnancy test at screening or have the intention to become pregnant during the course of the study.
•6\. Female subjects of childbearing potential or male subjects who have a female partner of childbearing potential, who either do not use or are not willing to use a medically reliable method of contraception or who are not sexually abstinent during the study, or not surgically sterile.
•7\. Alcohol, drug, or medication abuse within 1 year before the study.
•8\. Currently receiving a therapy not permitted during the study
•9\. Previous participation in a Voncento / Biostate study (patients can also not be enrolled a second time into the current study).