CTRI/2018/12/016521Other2 期
A Phase 2, single arm study of Safety and Efficacy of Coversin in adult aHUS subjects
试验速览
- 阶段
- 2 期
- 状态
- Other
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. 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 <150 X 109/ L
- •4. Evidence of AKI as per KDIGO guidelines.
- •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. Women of child-bearing potential are considered to remain so following menarche until becoming post-menopausal unless permanently sterilised. Permanent sterile methods include hysterectomy, bilateral salpingectomy, bilateral oophorectomy. Postmenopausal state is defined as no menses for 12 months without an alternative cause.
- •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
- •8. The patient is willing to comply with the process of preparation and self-administration of the study drug
排除标准
- •1. Thrombotic Thrombocytopenic Purpura (TTP), defined as ADAMTS13 activity <10% from a historical observation (prior to initiation of PT) or as tested at the screening visit.
- •2. Typical HUS (known Shiga toxin + or positive EHEC culture)
- •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)
研究者
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