EUCTR2007-003718-32-FR进行中（未招募）1 期
Randomized, active-controlled, double-blind, parallel design study to evaluate the efficacy and safety of a once-a-week prophylaxis treatment with BAY 79-4980 compared to three times-per-week prophylaxis with rFVIII-FS 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
- 143
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, inclusion of adolescent subjects will start after 20 adults have completed the run-in phase with acceptable tolerability and the DSMB has approved the start of recruitment of adolescent subjects
- •Subjects with severe hemophilia A (< 1% FVIII:C)
- •Subjects with equal or greater than 150 EDs with any FVIII in total
- •Subjects who have been on-demand treatment (no more than 40% of patients and at least 20% are high-frequency bleeders [=20 bleeds/year]) with an average of minimum 1 relevant bleed per month or have been on secondary prophylaxis treatment with not more than a 3x/week schedule with the history of minimum 12 relevant bleeds per year prior to be on secondary prophylaxis treatment
- •Subjects with bleeding events and/or treatments during the last 6 months prior to study entry which are documented in the subjects medical records.
- •Subjects with no measurable inhibitor activity using the Nijmegen-modified Bethesda assay (>0.6BU/mL is considered positive) in two consecutive samples and absence of clinical signs or symptoms of decreased response to FVIII administration.
- •Subjects with no history of FVIII inhibitor antibody formation. (=0.6BU/mL using the Nijmegen-modified Bethesda assay)
- •Subjects who complete an EPD (electronic patient diary) device training and demonstrate the ability to correctly use it
- •Written informed consent by subject and parent / legal representative, if
- •< 18 years
- •Only for subjects who are participating in the lipid-profile:
- •Subjects with no abnormal LDL- and total cholesterol profile prior to study entry and not on lipid-lowering drugs
- •Subjects who are willing to or able to comply with fasting requirements
- •12 hours overnight fasting followed by additional 3 hours after injection. Subjects may have water only.
- •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
- •Subjects who are receiving primary prophylaxis (start of prophylaxis before or directly after the first joint bleed without relevant interruptions)
- •Subjects on prophylaxis with documented requirements of > 75 IU/kg/week
- •Subjects with any other bleeding disease beside hemophilia A (i.e., von Willebrand disease)
- •Subjects with thrombocytopenia (platelets < 100,000/mm3)
- •Subjects with abnormal renal function (serum creatinine > 2.0 mg/dL)
- •Subjects with elevated hepatic transaminases (AST or ALT > 5xULN)
- •Subjects on treatment with immunomodulatory agents within the last 3 months prior to study entry or during the study (the following drugs are allowed: interferon-alpha-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)
- •Subjects with an absolute CD4 lymphocyte cell count < 250 cells/mm3
- •Subjects with positive Lupus Anticoagulant antibodies or history thereof
- •Subjects with known hypersensitivity to the active substance, mouse or hamster protein, liposomes or PEG
- •Subjects with severe dyslipidemia of all causes LDL-C = 190 mg/dl)
- •Subjects who are receiving or had received other experimental drugs within 3 months prior to study entry
- •Subjects who require any pre-medication for FVIII injections (e.g. anti-histamines)
- •Subjects with uncontrollable hypertension (diastolic blood pressure > 100 mmHg)
- •Subjects with known unstable coronary artery angina and/or with known history of myocardial infarction.
- •Subjects who are unwilling to comply with study visits or the treatment regimens
- •Subjects who have planned major surgery (including orthopedic) or radioisotopic synovectomy during the study
- •Subjects who are not suitable for participation in this study for any reason, according to the Investigator
- •Only for subjects who are participating in the PK sub-study:
- •Subjects who are receiving any pegylated medication (e.g. PEG interferon) in the month prior to the PK session
研究者
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