CTRI/2017/04/008336进行中（未招募）2 期
A Multicenter, Phase 2 Open-Label, Single-Arm, Prospective, InterventionalStudy of Plasma-Derived Factor VIII/VWF (Alphanate�®) in Immune Tolerance InductionTherapy in Subjects with Congenital Hemophilia A and Inhibitors - Nil
Spectrum Clinical Research Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. The subject has a documented diagnosis of severe congenital hemophilia A with FVIII:C <1% of normal.
- •2. The subject is a male ââ?°Â¥2 and <8 years of age at the Baseline Visit.
- •3. The subjectââ?¬•s documented historical peak inhibitor titer is ââ?°Â¥10 Bethesda units (BU) and ââ?°Â¤200 BU.
- •4. The subject has an inhibitor titer >0.6 BU and <10 BU at Screening.
- •5. The subject has had a delay ââ?°Â¤24 months from the date of diagnosis of the inhibitor to the start of the subjectââ?¬•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.
排除标准
- •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 has a known infection with human immunodeficiency virus (HIV) or has clinical signs and symptoms consistent with current HIV infection.
- •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 Screeningââ?¬â?imaging studies without investigative treatments are permittedââ?¬â?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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