EUCTR2015-005524-26-ES进行中（未招募）1 期
A Multicenter Phase 2 Open-Label, Single-Arm, Prospective, Interventional Study of Plasma-Derived Factor VIIIIVWF Alphanate®in Immune Tolerance Induction Therapy in Subjects with Congenital Hemophilia A.
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
- 25
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
- •Inclusion Criteria:
- •A subject must meet all of the following inclusion criteria at the time of the Screening/Baseline Visit (as specified below) to be eligible for participation in the study:
- •1. The subject has a documented diagnosis of severe congenital hemophilia A with FVIII:C <1% of normal.
- •2. The subject is a male <8 years of age at the Baseline Visit.
- •3. The subject’s documented historical peak inhibitor titer is =10 Bethesda units (BU) and =200 BU.
- •4. The subject has an inhibitor titer >0.6 BU and <10 BU at Screening.
- •5. The subject has had a delay =24 months from the date of diagnosis of the inhibitor to the start of the subject’s ITI treatment.
- •6. The subject has a caregiver willing to participate and comply with requirements of the protocol, including home infusions, blood sampling, and daily diary for the duration of the trial.
- •7. The subject has provided signed assent, if applicable (per Institutional Review Board or Ethics Committee requirements), and a parent or legal guardian has provided signed informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 25
- •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
- •Exclusion Criteria:
- •A subject meeting any of the following exclusion criteria is not eligible for participation in the study:
- •1. The subject has acquired factor VIII (FVIII) deficiency.
- •2. The subject has previously received ITI treatment.
- •3. The subject has a recent (within 1 month) history of central line infection at the time of Screening.
- •4. The subject has a high risk of cardiovascular, cerebrovascular, or thromboembolic event as judged by the investigator.
- •5. The subject is currently undergoing treatment with immunosuppressive drugs (eg, systemic corticosteroids), azathioprine, cyclophosphamide, high dose immunoglobulin,
- •interferon, or the use of a protein A column or plasmapheresis and is unwilling to discontinue these treatments starting at the screening visit.
- •6. The subject is positive for human immunodeficiency virus by nucleic acid amplification technology at Screening.
- •7. The subject has a known previous infection with hepatitis B virus or hepatitis C virus or has clinical signs and symptoms consistent with current HBV or HCV infection.
- •8. The subject has significant proteinuria, has a history of acute renal failure or severe renal impairment (blood urea nitrogen or creatinine >2 times the upper limit of normal), or is
- •receiving dialysis at Screening.
- •9. The subject has a value of aspartate transaminase or alanine aminotransferase >2 times the upper limit of normal at Screening.
- •10. The subject has clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may interfere with successful completion of the trial or place
- •the subject at undue medical risk.
- •11. The subject has a history of anaphylaxis or severe systemic reaction to any plasma-derived or other blood products.
- •12. The subject has participated in another clinical trial of an Investigational Product within 30 days prior to Screening—imaging studies without investigative treatments are
- •permitted—or has received any investigational blood product within the previous 3 months.
- •13. In the opinion of the investigator, the subject or caregiver may have compliance problems with the protocol or the procedures of the protocol.
研究者
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This is a multicenter, multinational, prospective, single-arm, nonrandomized, open-label study of approximately 25 male subjects with congenital hemophilia A with FVIII inhibitors who will receive their first (primary)treatment with Alphanate. The study will be conducted at approximately 20 study centers.Inhibitors in patients with severe Congenital Haemophilia AMedDRA version: 20.0Level: HLTClassification code 10018847Term: Haematological disordersSystem Organ Class: 100000004851EUCTR2015-005524-26-ITGRIFOLS BIOLOGICALS INC.25
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