EUCTR2009-012149-43-DE进行中（未招募）不适用
A two part randomized, cross-over, open-label trial to evaluate the pharmacokinetics, efficacy, and safety profile of plasma-protein free recombinant FVIII formulated with sucrose (BAY 81-8973) in previously treated subjects with severe hemophilia A under prophylaxis therapy.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 67
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
- •Male, aged 12 to 65 years
- •Severe hemophilia A, defined as < 1% FVIII:C as determined by onestage clotting assay at the time of screening. If screening result turns
- •out to be equal to or higher than 1%, then severe hemophilia A may be confirmed by one of the following (as of Amd 6): Documented historical evidence from a recognized (certified)
- •clinical laboratory (acceptable to GCL) demonstrating < 1% FVIII:C as determined by one-stage clotting assay, or Assay results from a previous Bayer hemophilia clinical trial
- •=150 exposure days (ED) in total with any recombinant FVIII or plasma-derived FVIII only. Cryoprecipitate and fresh frozen plasma
- •treatments are not considered in this total. (as of Amd 1)
- •Currently receiving on-demand or any type of prophylaxis treatment regimen with any FVIII product
- •No current evidence of inhibitor antibody as measured by the Nijmegen modified Bethesda assay [<0.3 Bethesda units (BU/mL)] (as of Amd 5) in 2 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. Second negative, confirmatory sample testing must, in all cases, be performed by a central laboratory using the Nijmegen test. If a first recent sample is not available, then testing for 2 negative samples
- •must be performed by the central laboratory at least 1 week apart). Subjects may not receive FVIII within 72 hours (as of Amd 5) prior to
- •the collection of samples for inhibitor testing
- •No history of FVIII inhibitor formation, defined as inhibitor antibody < 0.6 BU/mL, by the Bethesda assay. However, patients with a maximum historical titer of 1.0 BU (as of Amd
- •5) with the Classical Bethesda assay on no more than 1 occasion but with at least 3 subsequent (as of Amd 1) successive negative results
- •(<0.6 BU) thereafter are also eligible
- •Willingness and ability to complete training in the use of the study
- •electronic patient diary (EPD) by the subject or a surrogate (a caregiver or family member over 18 years of age). (as of Amd 1) Note: this
- •criterion does not apply to Major Surgery Arm population (as of Amd 9)
- •Written informed consent by subject and parent/legal representative, if under age of consent per local regulation Part C: Additional criteria applicable to only the Major Surgery Arm population: (as of Amd 9)
- •Medically requires any type of major surgery which requires treatment with FVIII during the perioperative period. (as of Amd 9)
- •The surgery is scheduled to occur within 6 weeks of screening (as of Amd 9).
- •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 52
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Presence of another bleeding disease that is different from hemophilia A (e.g., von Willebrand disease,
- •hemophilia B)
- •Thrombocytopenia (platelet count < 100,000/mm3)
- •Abnormal renal function (serum creatinine > 2.0 mg/dL)
- •Presence of active liver disease verified by medical history or persistent and increased alanine aminotransferase
- •(ALT) or aspartate aminotransferase (AST) > 5x the upper limit of normal (ULN) or severe liver disease as
- •evidenced by an INR >4, hypoalbuminemia, and significant portal vein hypertension in the judgment of the
- •Investigator. (as of Amd 5)
- •Received treatment with immunomodulatory agents within the last 3 months prior to study entry or requires
- •treatment during the study. [The following drugs are allowed: interferon-a treatment for hepatitis C virus (HCV),
- •highly active antiretroviral therapy (HAART) for human immunodeficiency virus (HIV), and or a total of 2
- •courses of pulse treatment with steroids for a maximum of 7 days at 1 mg/kg or less].
- •Absolute CD4 lymphocyte cell count <250 cells/uL (as of Amd 5)
- •Receiving or has received other experimental drugs within 3 months prior to study entry, with the exception of
- •Bayer Kogenate (Bayer factor VIII study drugs) received in studies within 2 weeks prior to study entry (as of
- •Requires any pre-medication to tolerate FVIII injections (e.g., antihistamines)
- •Unwilling to comply with study visits or other protocol requirements or is not suitable for participation in this
- •study for any reason, according to the Investigator
- •Known hypersensitivity to hamster and mouse protein.
- •Any subject who cannot forego at least 3 days without receiving FVIII for washout purposes.
研究者
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