EUCTR2013-003305-25-AT进行中（未招募）1 期
An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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,
- •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
- •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: 9
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 9
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •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.
研究者
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