EUCTR2014-001032-11-LT进行中（未招募）1 期
A Phase 2, uncontrolled, three-stage, dose-escalation cohort study toevaluate the safety, pharmacokinetics, pharmacodynamics,immunogenicity, and clinical activity of OMS721 in adults with thrombotic microangiopathies.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 89
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. Competent to provide informed consent.
- •2. Voluntarily provide informed consent in accordance with regulations and governing ethics committee requirements prior to any procedures or evaluations performed specifically for the sole purpose of the study.
- •3. Are age =18 at screening (Visit 1).
- •4. Have a diagnosis of TMA in accordance with one of the following three categories:
- •As of Amendment 10 of the Study Protocol, enrollment of aHUS subjects is closed. Primary aHUS, diagnosed clinically and having ADAMTS13 activity > 10% in plasma. Subjects are eligible with or without a documented complement mutation or anti-CFH antibody. Subjects are categorized according to their response to plasma therapy (plasma exchange or plasma infusion):
- •o Plasma therapy-resistant aHUS subjects must have all of the following:
- •1) screening platelet count < 150,000/µL despite at least four plasma therapy treatments prior to screening; 2) evidence of microangiopathic hemolysis (presence of schistocytes, serum lactate dehydrogenase (LDH) > upper limit of normal (ULN), or haptoglobin < LLN) and 3) serum creatinine > ULN.
- •o Chronic plasma therapy-responsive aHUS subjects (plasma
- •therapy-sensitive) must require at least once-per-week plasma therapy for four weeks before first dose of OMS721 with serum creatinine >ULN.
- •As of Amendment 10 of the Study Protocol, enrollment of TTP subjects is closed. TTP defined as having all of the following:
- •o Platelet count < 150,000/µL
- •o Evidence of microangiopathic hemolysis (presence of schistocytes, serum LDH > ULN, or haptoglobin < LLN)
- •o ADAMTS13 activity = 10% during the current episode of TTP or historically.
- •?Persistent HSCT-associated TMA defined as having all of the following at least two weeks following modification or discontinuation of calcineurin inhibitor treatment or at least 30 days after the transplant:
- •oPlatelet count < 150,000/?L
- •oEvidence of microangiopathic hemolysis (presence of schistocytes, serum LDH > ULN, or haptoglobin < LLN)
- •oRenal dysfunction (doubling of serum creatinine from pre-transplant).
- •5. No clinically apparent alternative explanation for thrombocytopenia and anemia.
- •6. If sexually active and of childbearing potential, must agree to practice a highly effective method of birth control until the end of the study, defined as one that results in a low failure rate (i.e., less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine devices, sexual abstinence or vasectomized partner.
- •Are the trial subjects under 18? no
- •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 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •Subjects will be excluded from the study for any of the following reasons:
- •1. Had eculizumab therapy within three months prior to screening.
- •2. Have STEC-HUS.
- •3. Have a positive direct Coombs test.
- •4. Have an active systemic bacterial or fungal infection requiring antimicrobial therapy (prophylactic antimicrobial therapy administered as standard of care is allowed).
- •5. Baseline resting heart rate < 45 beats per minute or > 115 beats per minute.
- •6. Baseline QTcF > 470 milliseconds.
- •7. Have malignant hypertension (diastolic blood pressure [BP] > 120 mm Hg with bilateral hemorrhages or cotton-wool” exudates on funduscopic examination).
- •8. Have a poor prognosis with a life expectancy of less than three months in the opinion of the investigator.
- •9. Are pregnant or lactating.
- •10. Have received treatment with an investigational drug or device within four weeks prior to screening.
- •11. Have abnormal liver function tests defined as ALT or AST > five times ULN.
- •12. Have a positive test for human immunodeficiency virus (HIV) antibodies.
- •13. Are an employee of Omeros, an investigator, a study staff member, or their immediate family member.
- •14. Have a known hypersensitivity to any constituent of the product.
- •15. Presence of any condition that the investigator believes would put the subject at risk.
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