EUCTR2016-003681-34-HU进行中（未招募）1 期
Clinical Study to Investigate the Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Patients with Severe Hemophilia A
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 55
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
- Male
入选标准
- •1. Severe hemophilia A (<1% FVIII:C) according to medical history 2. Male patients aged =12 years
- •3. Previous treatment with a FVIII concentrate for at least 150 exposure days (EDs)
- •4. Immunocompetence (CD4+ count >200/µL)
- •5. Good documentation of the historical bleeding rate (at least for the 6 months pre-ceding study start)
- •6. Voluntarily given, fully informed written and signed consent obtained by the pa-tient (or parent/legal guardian in case of adolescents) before any study-related pro-cedures are conducted
- •Whenever possible, the interval between the Screening Visit and the PK or Non-PK Visit should not exceed 30 days. If the 30-day interval is exceeded, determination of the CD4+ count is to be repeated and must be >200/µL for patients to be enrolled (i.e., inclusion criterion no. 4).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 10
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1. Any coagulation disorders other than hemophilia A
- •2. History of FVIII inhibitor activity (=0.6 BU) or detectable FVIII inhibitory anti-bodies (=0.6 BU using the Nijmegen modification of the Bethesda assay) at screening, as determined by the central laboratory
- •3. Severe liver or kidney diseases (alanine aminotransferase [ALAT] and aspartate transaminase [ASAT] levels >5 times of upper limit of normal, creatinine >120 µmol/L)
- •4. Patients receiving or scheduled to receive immunomodulating drugs (other than anti-retroviral chemotherapy) such as alpha-interferon, prednisone (equivalent to >10 mg/day), or similar drugs
- •5. Treatment with any investigational medicinal product in another interventional clinical study currently or within 4 weeks before enrollment
研究者
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