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Clinical Trials/EUCTR2013-003305-25-PL
EUCTR2013-003305-25-PLActive, not recruitingPhase 1

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 enrollmentStarted: November 10, 2015Last updated:
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Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
30
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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 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.
  • •9.Subjects who require a VWF product to control a NSB event or for
  • •ongoing prophylactic therapy.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 14
  • •F.1.2 Adults (18-64 years) yes
  • •F.1.2.1 Number of subjects for this age range 14
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 2

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).
  • •10. Mental condition rendering the subject (or the subject’s legally acceptable representative[s]) unable to understand the nature, scope, and possible consequences of the study.
  • •11. Any issue that, in the opinion of the investigator, would render the subject unsuitable for participation in the study.

Investigators

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