EUCTR2013-003305-25-AT
Active, not recruiting
Phase 1
An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease
DrugsVoncento
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CSL Behring GmbH
- Enrollment
- 20
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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\.Subjects of any age.
- •4\.Diagnosis of severe Type 1, 2A, or 3 VWD where VWF:RCo is \<20% at
- •5\.Availability of detailed patient documentation (eg, medical record,
Exclusion Criteria
- •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).
Outcomes
Primary Outcomes
Not specified
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