EUCTR2010-020558-33-PT进行中（未招募）不适用
A-LONG: An Open-label, Multicenter Evaluation of the Safety, Pharmacokinetics, and Efficacy of Recombinant Factor VIII Fc Fusion Protein (rFVIIIFc) in the Prevention and Treatment of Bleeding in Previously Treated Subjects With Severe Hemophilia A - A-LONG
Biogen Idec Hemophilia, Inc.0 个研究点目标入组 180 人开始时间: 2011年5月25日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 180
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.Provide written informed consent and any authorizations required by local law (e.g., Protected Health Information [PHI]). Parental or guardian consent is required for subjects who are less than 18 years of age. Subjects less than 18 years of age should consent to the study providing a signed assent form if required by local regulations.
- •2.Male, =12 years of age and weighing at least 40 kg
- •3.Have severe hemophilia A defined as <1 IU/dL (<1%) endogenous FVIII as determined by one-stage clotting assay from the central laboratory at the time of screening. If the screening result is =1%, then the severity of hemophilia A may be confirmed by documented historical evidence from a certified clinical laboratory demonstrating <1% FVIII:C as determined by the one-stage clotting assay from the medical record or from a documented genotype known to produce severe hemophilia A.
- •4.Previously treated subject, defined as having at least 150 documented prior exposure days to any recombinant and/or plasma-derived FVIII and/or cryoprecipitate products at Day 0 (Advate or rFVIIIFc). Fresh frozen plasma treatment must not be considered in the count for the documented exposure days.
- •5.No measurable inhibitor activity using the Nijmegen-modified Bethesda assay (=0.6 BU/mL is considered positive) 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 12 weeks prior to screening. The second confirmatory sample must in all cases be performed by the central laboratory using the Nijmegen modified Bethesda assay. If no recent sample is available, then 2 negative samples analyzed by the central laboratory at least 1 week apart should be obtained during screening). At least 96 hours washout of FVIII must have passed prior to collecting samples for inhibitor testing where possible (72 hours permitted during a repeat washout if the subject treats a bleeding episode prior to 96 hours on the first attempt).
- •6.No history of FVIII inhibitor antibody formation (=0.6 BU/mL using the Nijmegen-modified Bethesda assay; subjects with a maximum historical titer of 1.0 BU on no more than 1 occasion with the Classical Bethesda assay but at least 2 successive negative [<0.6 BU] results thereafter are also eligible)
- •7.History of bleeding events and/or treatment with FVIII during the prior 12 weeks, as documented in the subjects’ medical records
- •8.Willingness and ability of the subject or a surrogate (a caregiver or a family member =18 years of age) to complete training in the use of the study EPD and to use the EPD throughout the study
- •9.For subjects entering Arm 1: Currently on a prophylaxis regimen at least 2 times per week with a FVIII product or on an on-demand regimen with =12 bleeding episodes in the 12 months prior to Day 0 (Advate or rFVIIIFc)
- •10.For subjects entering Arm 2 or 3: Currently on an on-demand regimen with =12 bleeding \episodes in the 12 months prior to Day 0 (rFVIIIFc)
- •The following inclusion criteria refer to tests by the central laboratory sampled at screening and reviewed prior to Day 0 (Advate or rFVIIIFc):
- •11.Platelet count >100,000 cells/µL
- •12.International normalized ratio (INR) =1.30, as defined by the testing laboratory’s normal range
- •13.Immunocompetent: CD4 lymphocytes >200 mm3
- •14.Viral load of <400 copies/mL, if human immunodeficiency virus (HIV) antibody positive
- •Are the trial subjects under
排除标准
- •1.History of, or currently detectable inhibitor titer as defined by the central laboratory (family history of inhibitors will not exclude the subject)
- •2.Other coagulation disorder(s) in addition to hemophilia A
- •3.History of hypersensitivity or anaphylaxis associated with any FVIII or IV immunoglobulin administration
- •4.For the PK subgroup only: known hypersensitivity to mouse or hamster proteins
- •5.Currently taking (or likely to require during the study) acetylsalicylic acid (ASA) or ibuprofen (other non-steroidal anti-inflammatory drugs are permitted)
- •6.Concurrent systemic treatment with immunosuppressive drugs 12 weeks prior to Day 0 (Advate or rFVIIIFc). (Exceptions: ribavirin, treatment of hepatitis C virus [HCV] and HIV and/or systemic steroids [a total of 2 courses of pulse treatments within 7 days =1 mg/kg] and/or inhaled steroids)
- •7.Major surgery within the previous 8 weeks
- •8.Unable to enter accurate and timely information regarding injections and bleeding episodes into an EPD and without adequate parental/caregiver support to manage this (per the Investigator’s judgment)
- •9.Unable or unwilling to refrain from taking additional prophylactic doses of rFVIII prior to sports activities or an increase in physical activity
- •10.Current enrollment or enrollment within the past 30 days in any other clinical trial involving investigational drugs.
- •11.Any concurrent clinically significant major disease or other unspecified reasons that, in the opinion of the Investigator, makes the subject unsuitable for participation in the study
- •The following exclusion criteria refer to tests by the central laboratory sampled at screening and reviewed prior to Day 0 (Advate or rFVIIIFc):
- •12.Abnormal renal function (serum creatinine >2.0 mg/dL)
- •13.Serum alanine transaminase (ALT) or aspartate aminotransferase (AST) >5x upper limit of normal (ULN)
- •14.Serum bilirubin >3x ULN
研究者
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