EUCTR2017-000064-15-GB进行中（未招募）1 期
A Phase 2, single arm study of Safety and Efficacy of Coversin in adult aHUS subjects
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 10
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
入选标准
- •1.18 years and older at the time of consent.
- •2.LDH at screening or at the onset of the current aHUS episode was = 1.5 ULN.
- •3.Platelet count at screening or at the onset of the current aHUS episode < 150 X 10*9/L.
- •4.Evidence of AKI as per KDIGO guidelines [1]. (Increase in SCr by = 0.3 mg/dl (26.5 µmol/l) within 48 hours; or Increase in SCr to = 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days, OR Urine volume 0.5 ml/kg/h for 6 hours.
- •5.Males and females of childbearing potential must agree to use an adequate method of contraception. Females will have a negative serum pregnancy test before entry to the study and throughout the study.
- •6.The patient has given voluntary written informed consent.
- •7. Willing to receive immunisation against Neisseria meningitidis and antibiotic prophylaxis in accordance with the KDIGO guidelines and local standard of care of the PI at each trial site.
- •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 8
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •1.Thrombotic Thrombocytopenic Purpura (TTP), defined as ADAMTS13 activity <10% from an historical observation (prior to initiation of Plasma Therapy) or as tested at the screening visit.
- •2.STEC HUS (known Shiga toxin positive or EHEC (En-terohaemorrhagic Escherichia coli)) positive cultures.
- •3.HUS related to known HIV infection.
- •4.Identified drug exposure-related HUS.
- •5.HUS related to bone marrow transplant (BMT).
- •6.HUS related to Cobalamin (vitamin B12) deficiency.
- •7.Patients with a confirmed diagnosis of sepsis defined as positive blood cultures within 7 days of the screening visit and not treated with antibiotics to which the organism is sensitive.
- •8.Presence or suspicion of active and untreated systemic bacterial infection that, in the opinion of the Investigator confounds an accurate diagnosis of aHUS or impedes the ability to manage the aHUS disease.
- •9.Unresolved meningococcal disease.
- •10.Known Systemic Lupus Erythematosus (SLE) or antiphospholipid antibody positivity or syndrome.
- •11.Prior use of eculizumab (Soliris®) within 2 months of screening is prohibited.
- •12.Exposure to any other investigational drug acting directly on the complement system within 5 half-lives of screening is prohibited.
- •13.Chemotherapeutic agents within 3 months of enrolment in the study are prohibited.
- •14.History of malignancy within 5 years of screening.
- •15.Known sensitivity to the excipients of meningococcal vaccines, ciprofloxacin or any other antibiotic being administered for purposes of meningitis prophylaxis.
- •16.Participation in other clinical trials within 4 weeks of signing the ICF.
- •17.Known allergy to ticks or severe reaction to arthropod venom (e.g. bee or wasp venom).
- •18.History of active systemic autoimmune diseases other than the target condition. Dermatologic diseases such as psoriasis will not be a reason for exclusion unless there are associated systemic symptoms such as arthritis.
- •19.Any severe systemic disorder that could interfere with the evaluation of the study treatment (e.g. hepatic disease) that in the opinion of the Investigator would affect the outcome of the study or interfere with interpretation of results.
- •20.Failure to satisfy the Investigator of fitness to participate for any other reason or any condition (e.g. severe depression or psychiatric disorder) which, in the opinion of the investigator, could increase the subject's risk by participating in the study or confound the outcome of the study.
- •21.If female, the subject is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after last dose; or intending to donate ova during such period.
- •22.If male, the subject intends to donate sperm during this study or for 90 days after last dose.
- •23.The subject is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g. spouse, parent, child, sibling) or may consent under duress.
- •24. The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to screening.
研究者
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