EUCTR2008-004922-18-BG进行中（未招募）不适用
An Open-label, Multi-centre Study to Assess the Pharmacokinetics, Efficacy and Safety of Biostate® in Subjects with Von Willebrand Disease.
适应症
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
- •1. Male and female subjects who are at least 12 years of age. 2. Diagnosed with VWD where VWF:RCo is <15% at screening (after a minimum of 5 days since last VWF treatment) or the subject has a history of VWF:RCo <10% documented in their medical notes at enrolment. 3. Where DDAVP treatment is ineffective or contraindicated. 4. Require a VWF product for prophylactic therapy or to control a NSB event. 5. Have evidence of vaccination against hepatitis A and B (or presence of antibodies against hepatitis A and B due to either a previous infection or immunisation) within 10 years prior to their first dose of Biostate documented in their medical notes. 6. The subject and/or their legally acceptable representative understands the nature of the study, gives written informed consent to participate in the study and is willing and able to comply with the protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •For participants of the PK study: 1. Are actively bleeding immediately prior to initial PK period. 2. Have received DDAVP or a VWF product in the 5 days prior to their first dose of study product. 3. Have Type 2B, 2N or 2M VWD. For all subjects: 4. Requiring a VWF product for a planned surgical procedure at enrolment (treatment with Biostate for surgical procedures subsequent to enrolment in the study is allowed but a planned surgery should not be the reason for inclusion into the study). 5. Have received aspirin or other NSAIDs within 7 days prior to their first dose of study product. 6. Have a known history of, or are suspected to have VWF or FVIII inhibitors. 7. Suffering an acute or chronic medical condition, other than VWD, which may, in the opinion of the Investigator, affect the conduct of the study. 8. Have a known or suspected hypersensitivity or previous evidence of severe side effects to Biostate, VWF/FVIII concentrates or human albumin. 9. Subjects with impaired liver function at screening i.e. bilirubin >1.5 x upper limit of normal (ULN) and/or, AST/ALT >2.5 x ULN (referring to the limits of the laboratory that performs the determination). 10. Subjects having evidence or a history (within the previous 12 months) of abuse of any drug substance, licit or illicit. 11. Have participated in a clinical study or used an investigational compound (e.g. a new chemical entity not registered for clinical use) in the three months preceding the first day of study drug administration, or who are planning to enter such a study during the study period. 12. Female subjects who are pregnant, breast-feeding or who have a positive pregnancy test at screening. The Investigator must confirm that a reliable form of contraception will be used for the duration of the study.
研究者
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