EUCTR2013-003305-25-PT进行中（未招募）不适用
An Open-label, Multi-centre Post-marketing Study to Assess the Efficacy and Safety of Voncento® in Subjects with Von Willebrand Disease
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 30
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. 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
- •Number of subjects for this age range: 18
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •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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