CTRI/2020/01/022716进行中（未招募）3 期
A Phase 3, Prospective, Multicenter, Open-label, Randomized, Crossover Study of Tolerability and Safety of FEIBA Reconstituted in Regular or 50% Reduced Volume and of Faster Infusion Rates in Patients with Hemophilia A or B with Inhibitors
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
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.ââ?°Â¥ 18 to ââ?°Â¤ 65 years old at the time of screening
- •2.Hemophilia A or B of any severity, with a documented ââ?°Â¥ 3 months history of inhibitors (ââ?°Â¥ 0.6 BU) requiring the use of bypassing agents (FEIBA or rFVIIa) prior to screening. Inhibitor level will be tested at screening if no documented history is available.
- •3.Hepatitis C virus (HCV) negative, either by antibody testing or polymerase chain reaction (PCR); or HCV positive with stable liver disease
- •4.Human immune deficiency virus (HIV) negative; or HIV positive with stable disease and CD4 count ââ?°Â¥ 200 cell/mm3 at screening
- •5.Adequate venous access
- •6.Willing and able to comply with the requirements of the protocol
- •7.If a female of childbearing potential, must have a negative blood pregnancy test and agrees to employ adequate birth control measures for the duration of the study, such as:
- •a.Abstain from sexual intercourse
- •b.Use a reliable method of contraception (contraception such as an intrauterine device, barrier method [e.g., diaphragm or sponge; female condom not permitted] with spermicide, oral contraceptive, injectable progesterone, sub dermal implant), and have their male partner use a condom
- •8.If female of non-childbearing potential, confirmed at screening by fulfilling 1 of the following criteria:
- •a.Postmenopausal, defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle-stimulating hormone levels within the laboratory-defined postmenopausal range or postmenopausal with amenorrhea for at least 24 months and on hormonal replacement therapy
- •b.Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, bilateral tubal ligation (with no subsequent pregnancy at least 1 year from bilateral tubal ligation), or bilateral salpingectomy
排除标准
- •Inclusion criteria
- •Subject is/has:
- •1.ââ?°Â¥ 18 to ââ?°Â¤ 65 years old at the time of screening
- •2.Hemophilia A or B of any severity, with a documented ââ?°Â¥ 3 months history of inhibitors (ââ?°Â¥ 0.6 BU) requiring the use of bypassing agents (FEIBA or rFVIIa) prior to screening. Inhibitor level will be tested at screening if no documented history is available.
- •3.Hepatitis C virus (HCV) negative, either by antibody testing or polymerase chain reaction (PCR); or HCV positive with stable liver disease
- •4.Human immune deficiency virus (HIV) negative; or HIV positive with stable disease and CD4 count ââ?°Â¥ 200 cell/mm3 at screening
- •5.Adequate venous access
- •6.Willing and able to comply with the requirements of the protocol
- •7.If a female of childbearing potential, must have a negative blood pregnancy test and agrees to employ adequate birth control measures for the duration of the study, such as:
- •a.Abstain from sexual intercourse
- •b.Use a reliable method of contraception (contraception such as an intrauterine device, barrier method [e.g., diaphragm or sponge; female condom not permitted] with spermicide, oral contraceptive, injectable progesterone, sub dermal implant), and have their male partner use a condom
- •8.If female of non-childbearing potential, confirmed at screening by fulfilling 1 of the following criteria:
- •a.Postmenopausal, defined as amenorrhea for at least 12 months following cessation of all exogenous hormonal treatments and with follicle-stimulating hormone levels within the laboratory-defined postmenopausal range or postmenopausal with amenorrhea for at least 24 months and on hormonal replacement therapy
- •b.Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, bilateral tubal ligation (with no subsequent pregnancy at least 1 year from bilateral tubal ligation), or bilateral salpingectomy
- •Subject is/has:
- •1.Known hypersensitivity to FEIBA or any of its components
- •2.Advanced liver disease (e.g., liver biopsy confirmed diagnosis of cirrhosis, portal vein hypertension, ascites, prothrombin time [PT] 5 seconds above upper limit of normal)
- •3.Planned elective surgery during participation in this study (excluding minor procedures that will not need preventative bleeding treatments, such as exchanges of peripherally inserted central catheters)
- •4.Platelet count < 100,000/Ã?¼L
- •5.Taking Emicizumab (Hemlibra) for bleed prevention
- •6.Clinical or laboratory evidence of disseminated intravascular coagulation based on medical history
- •7.Prior history or evidence of thromboembolic event: acute myocardial infarction, deep vein thrombosis, pulmonary embolism, etc.
- •8.Diagnosis of advanced atherosclerosis, malignancy, and/or other diseases that may increase the subjectââ?¬•s risk of thromboembolic complications
- •9.Taking any immunomodulating drug (e.g., corticosteroid agents at a dose equivalent to hydrocortisone > 10 mg/day, or Ã?±-interferon) within 30 days prior to enrollment except anti-retroviral chemotherapy.
- •10.Herbal supplements that contain anti-platelet activity
- •11.Participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment or is scheduled to participate in another
研究者
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