EUCTR2006-004458-26-SK进行中（未招募）1 期
Randomized, comparative, open label treatment with double-blind placebo-controlled periods within treatment study to evaluate the efficacy and safety of a once-a-week prophylaxis treatment with BAY 79-4980 compared to once-a-week prophylaxis treatment and to on-demand treatment with rFVIII-FS reconstituted with water for injection 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
- 285
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
- •Males aged 12 to 70 years
- •Severe hemophilia A (< 1% FVIII:C)
- •150 ED with any FVIII, > 20 ED during last year
- •On-demand treatment for the past year (Subjects having received isolated courses of prophylaxis for 6 consecutive weeks or less in a maximum of 2 occasions in the previous 12 months are also eligible)
- •At least 20 documented bleeds during the last 12 months (Or equivalent annualized bleeding frequency in no less than the previous 6 months, or documented corresponding infusions > 4 days apart, or if the treating physician confirms this bleeding frequency and this information is documented in the subjects medical records or a combination of them).
- •No current evidence of inhibitor antibody measured using the Nijmegen modified Bethesda assay (<0.6 BU/mL) in two consecutive samples and absence of clinical signs or symptoms of decreased response to FVIII administration. (First negative sample can be historical if obtained within 3 months prior to screening and measured by Nijmegen. Second sample –confirmatory- must in all cases be performed by the central lab. If a first recent sample is not available then 2 negative samples by central lab at least 1 week apart should be obtained). At least 3 days without receiving FVIII must have passed prior to collect samples for inhibitors.
- •No history of FVIII inhibitor antibody formation. (Subjects with a maximum historical titer of 1.0 BU in no more than one occasion with the Classical Bethesda assay but at least three successive negative [<0.6 BU] thereafter are also eligible)
- •Written informed consent by subject and parent / legal representative, if < 18 years
- •Are the trial subjects under 18? no
- •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
- •Individuals with von Willebrand disease
- •Any individual with thrombocytopenia (platelets < 100 000/mm3)
- •Any individual with abnormal renal function (serum creatinine > 2.0 mg/dL)
- •Any individual with active hepatic disease (AST or ALT > 5xULN)
- •Any individual on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study. (the following drugs are allowed: alpha interferon treatment for HCV, HAART therapy for HIV and/or a total of two courses of pulse treatment with steroids for a maximum of 7 days at 1mg/kg or less)
- •Any individual with (HIV, HCV or due to another suspicious condition) an absolute CD4 lymphocyte cell count < 250 cells/mm3
- •Individuals with positive Lupus Anticoagulant antibodies
- •Any individual with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or PEG
- •Any individual who was receiving or had received other experimental drugs within 3 months prior to study entry
- •Any individual who required any pre-medication for FVIII infusions (e.g. anti-histamines)
- •Any individual with hypertension (diastolic blood pressure > 100 mmHg) which is uncontrollable with proper medication
- •Any individual with known unstable coronary artery angina and/or with known history of myocardial infarction.
- •Any individual who is unwilling to comply with study visits or any of the possible treatment regimens (e.g. not willing to receive on-demand treatment for one year)
- •Planned major surgery (including orthopedic) during the study
- •Planned radio-isotopic synovectomy during the study
- •Any individual who is not suitable for participation in this study for any reason, according to the Investigator
- •Only for subjects participating in the PK substudy:
- •oAny individual receiving any pegylated medication (i.e. PEG interferon) in th
- •e month prior to the PK session
- •oAny subject not willing to or able to comply with fasting requirements (from 10pm previous night until 6 hours post infusion)
研究者
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