EUCTR2011-000410-18-BE进行中（未招募）1 期
A PHASE 3b CLINICAL STUDY TO ASSESS WHETHER REGULAR ADMINISTRATION OF ADVATE IN THE ABSENCE OF IMMUNOLOGICAL DANGER SIGNALS REDUCES THE INCIDENCE RATE OF INHIBITORS IN PREVIOUSLY UNTREATED PATIENTS WITH HEMOPHILIA A - EARLY PROPHYLAXIS IMMUNOLOGIC CHALLENGE (EPIC) STUDY
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
- 100
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
- •Subjects who meet all of the following criteria are eligible for this study:
- •Subjects with severe and moderately severe hemophilia A (FVIII = 2%)
- •Certain FVIII mutation types (eg, large multi-domain deletions; nonsense mutations; insertions/deletions/inversions that result in a premature stop codon; intron 22 inversions) can be used to corroborate a severe hemophilia A phenotype when laboratory assays show FVIII levels = 1% because of rounding errors or carryover effect from a previous FVIII administration; a central laboratory FVIII assay is required to confirm subject eligibility.
- •Subjects < 1 year of age.
- •Subjects must have = 3 EDs to any FVIII concentrate or FVIII-containing product used for treatment of minor bleeds (bleeds requiring no more than 2 infusions per event), or for preventative or precautionary infusions following possible injury.
- •Subjects with prior circumcision are allowed to enroll only if bleeding issues related to circumcision were the cause for the original diagnosis of hemophilia A and if no more than 2 EDs of FVIII were required.
- •Adequate venous access (without need for central venous access device [CVAD]-placement) as determined by the physician
- •Written informed consent from legally authorized representative(s)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 100
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Life-threatening conditions (intracranial hemorrhage, severe trauma), or requirement for surgery at the time of enrollment
- •Evidence of inhibitor =0.6 BU in Njimegen-modified Bethesda Assay at study start (samples may be retested using lupus-insensitive inhibitor tests to reduce the number of false positive inhibitortesting for lupus anticoagulant will be done to eliminate false positives)
- •Inherited or acquired hemostatic defect other than hemophilia A
- •Any clinically significant, chronic disease other than hemophilia A
- •Known hypersensitivity to ADVATE or any of its constituents
- •Any planned elective surgery that cannot be postponed until after the first 20 EDs
- •Participation in the Hemophilia Inhibitor PUP Study (HIPS)
- •Application of red blood cell, platelet, or leukocyte concentrates, or plasma
- •Administration of any medication affecting coagulation or platelet function
- •Systemic administration of any immunomodulatory drug (eg, chemotherapy, intravenous glucocorticoids)
- •Participation in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or during the course of this studySubjects who meet any of the following criteria are not eligible for this study:
- •Life-threatening conditions (intracranial hemorrhage, severe trauma), or requirement for surgery at the time of enrollment
- •Evidence of inhibitor = 0.6 BU in Njimegen-modified Bethesda Assay at study start (samples may be retested using lupus-insensitive inhibitor tests to reduce the number of false positive inhibitor)
- •Inherited or acquired hemostatic defect other than hemophilia A
- •Any clinically significant, chronic disease other than hemophilia A
- •Known hypersensitivity to ADVATE or any of its constituents
- •Any planned elective surgery that cannot be postponed until after the first 20 EDs
- •Participation in the Hemophilia Inhibitor PUP Study (HIPS)
- •Application of red blood cell, platelet, or leukocyte concentrates, or plasma
- •Administration of any medication affecting coagulation or platelet function
- •Systemic administration of any immunomodulatory drug (eg, chemotherapy, intravenous glucocorticoids)
- •Participation in another clinical study involving an investigational product (IP) or device within 30 days prior to study enrollment or during the course of this study
研究者
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