EUCTR2005-000347-29-HU进行中（未招募）不适用
ADVATE ANTIHEMOPHILIC FACTOR (RECOMBINANT), PLASMA/ALBUMIN FREE METHOD (ADVATE rAHF PFM): A PHASE 4 STUDY COMPARING TWO PROPHYLACTIC REGIMENS IN SUBJECTS WITH SEVERE OR MODERATELY SEVERE HEMOPHILIA A - Advate Prophylaxis Phase IV
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Baxter AG
- 入组人数
- 66
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
- All
入选标准
- •1. The subject or the subject’s legally authorized representative has provided written informed consent.
- •2. The subject has severe or moderately severe hemophilia A as defined by a baseline factor VIII level less than or equal 2% of normal, as tested at screening.
- •3. The subject has a documented history of at least 150 exposure days to factor VIII concentrates (either plasma-derived or recombinant).
- •4. The subject is within 7 to 65 years of age.
- •5. The subject has a Karnofsky performance score > 60.
- •6. The subject is human immunodeficiency virus negative (HIV-) or is HIV+ with a stable CD4 count more than or equal 400 cells/mm³ (CD4 count determined at screening, if necessary).
- •7. The subject has been on a documented on-demand treatment regimen for at least 12 months immediately prior to enrollment.
- •8. The subject has a documented history (e.g. in medical charts, dispensing information or signed investigator statement) of at least 8 joint hemorrhages in the 12 months immediately prior to enrollment.
- •9. The subject resides within the coverage area of the mobile compliance device; coverage area will be determined at screening.
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The subject has a known hypersensitivity to factor VIII concentrates or mouse or hamster proteins.
- •2. The subject has a history of factor VIII inhibitors with a titer more than or equal 0.6 BU (by Bethesda or Nijmegen assay) at any time prior to screening.
- •3. The subject has a detectable factor VIII inhibitor at screening, with a titer more than or equal 0.4 BU (by Nijmegen Assay) in the central laboratory.
- •4. The subject has severe chronic liver disease as evidenced by, but not limited to, any of the following: International Normalized Ratio (INR) > 1.4, hypoalbuminemia, portal vein hypertension including presence of otherwise unexplained splenomegaly and history of esophageal varices.
- •5. The subject has been diagnosed with an inherited or acquired hemostatic defect other than hemophilia A (e.g., qualitative platelet defect or von Willebrand’s Disease).
- •6. The subject has been treated during the last sixty (60) days prior to or is being treated at screening/enrollment with an immunomodulating drug.
- •7. The subject has participated in another investigational study within 30 days of enrollment.
- •8. The subject has previously participated in a clinical study with ADVATE rAHF PFM.
- •9. The subject’s clinical condition may require a major surgery (defined as moderate to critical risk and perioperative blood loss more than or equal 500 mL) during the period of the subject’s participation in the study.
- •10. The subject is female of childbearing potential with a positive pregnancy test.
研究者
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