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临床试验/EUCTR2010-020558-33-SE
EUCTR2010-020558-33-SE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1月14日最近更新:
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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
研究概览入排标准研究者记录与标识符相似试验

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 (or as per local regulations). Subjects less than 18 years of age (or as per local regulations) 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 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 at least 1 week apart and analyzed by the central laboratory using the Nijmegen-modified Bethesda assay should be obtained during screening.)
  • •6.History of bleeding events and/or treatment with FVIII during the prior 12 weeks, as documented in the subjects’ medical records
  • •7.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
  • •8.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)
  • •9.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 criterion refers to tests by the central laboratory sampled at screening and reviewed prior to Day 0 (Advate or rFVIIIFc):
  • •10.Platelet count=100,000 cells/µL
  • •The following inclusion criteria refer to tests performed within 6 months prior to Screening. If not available, the test should be conducted by the central laboratory, sampled at screening and reviewed prior to Day 0 (Advate or rFVIIIFc):
  • •11. CD4 lymphocytes >200 mm3 if known as human immunodeficiency virus (HIV) antibody positive,
  • •12.Viral load of 400 copies/mL if known HIV antibody positive
  • •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 140
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 4

排除标准

  • •1.History of, or currently detectable inhibitor A positive inhibitor value is =0.6 BU/mL (or any value greater than or equal to the lower sensitivity cut-off for laboratories with cut-offs for inhibitor detection between 0.7 and 1.0 BU/mL). (In addition, the following documentation should be provided:
  • •-at least 2 negative inhibitor tests prior to the screening test AND
  • •-within the past 5 years (or since start of treatment with FVIII or cryoprecipitate, if available) absence of clinical suspicion of inhibitors (from medical records and patient history - no evidence of decreased therapeutic response due to inhibitors and normal FVIII recovery, as available).
  • •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

发起方
Biogen Idec Hemophilia, Inc.

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