ISRCTN31882639终止2 期
A phase II, dose-ranging study in patients with Paroxysmal noctuRnal haemoglobINuria, treated with Cemdisiran and Eculizumab
niversity of Leeds0 个研究点目标入组 9 人开始时间: 2019年5月15日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
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
- 性别
- All
入选标准
- •Current participant inclusion criteria as of 30/07/2019:
- •1. Aged at least 18 years
- •2. Diagnosis of PNH and on eculizumab therapy for a minimum of 90 days at a stable dose (i.e. the dose of eculizumab has not changed in the previous 90 days)
- •3. Women of child-bearing potential1 (WOCBP) must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use a highly effective method of contraception 14 days before cemdisiran administration, throughout study participation, and for 6 months after cemdisiran administration
- •4. Male participants with partners that are WOCBP must use double-barrier contraception (male condom plus appropriate barrier method for the female partner) for 14 days before cemdisiran administration, throughout study participation, and for 6 months after cemdisiran administration. Male participants must not donate sperm while on treatment and for at least 6 months after last dose of cemdisiran
- •5. Willing and able to comply with the study requirements and to provide written informed consent
- •6. Vaccinated against Neisseria meningitidis according to standard practice
- •Previous participant inclusion criteria:
- •1. Aged at least 18 years
- •2. Diagnosis of PNH and on eculizumab therapy for a minimum of 90 days at a stable dose of 900mg (i.e. the dose of eculizumab has not changed in the previous 90 days)
- •3. Women of child-bearing potential1 (WOCBP) must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use a highly effective method of contraception 14 days before cemdisiran administration, throughout study participation, and for 6 months after cemdisiran administration
- •4. Male participants with partners that are WOCBP must use double-barrier contraception (male condom plus appropriate barrier method for the female partner) for 14 days before cemdisiran administration, throughout study participation, and for 6 months after cemdisiran administration. Male participants must not donate sperm while on treatment and for at least 6 months after last dose of cemdisiran
- •5. Willing and able to comply with the study requirements and to provide written informed consent
- •6. Vaccinated against Neisseria meningitidis according to standard practice
排除标准
- •1. Alanine transaminase (ALT) =2 ×ULN, or total bilirubin =4×ULN (unless bilirubin elevation is due to Gilbert’s syndrome), and considered clinically relevant in the opinion of the Investigator
- •2. Spontaneous vascular thrombosis within 90 days of registration (patients may be rescreened)
- •3. History of bone marrow transplantation
- •4. Clinical laboratory test results considered clinically relevant and unacceptable in the opinion of the Investigator
- •5. Planned change in eculizumab dose within 90 days of administration of cemdisiran (patients may be rescreened)
- •6. Known or suspected hereditary asymptomatic complement deficiency
- •7. Known clinical laboratory evidence or clinical diagnosis of human immunodeficiency virus (HIV) infection, hepatitis C virus (HCV) infection, or chronic hepatitis B virus (HBV) infection as shown by hepatitis B surface antigen positivity in the blood
- •8. Presence or suspicion of active viral, bacterial, fungal, or parasitic infection within 14 days before cemdisiran administration (patients may be rescreened)
- •9. Travelled to Saudi Arabia or Africa within 90 days of Screening, or planning to do so during the study (patients may be rescreened)
- •10. Received a complement targeted investigational agent within 90 days prior to screening (or 5 half-lives) depending which is longer
- •11. In follow-up of another clinical trial before trial registration
- •12. Active serious mental illness or psychiatric disorder, including, but not limited to, schizophrenia, bipolar disorder, or severe depression requiring current pharmacological intervention
- •13. Other medical conditions or comorbidities which, in the opinion of the Investigator, would interfere with study compliance or data interpretation
- •14. History of multiple drug allergies or history of allergic reaction to an oligonucleotide or N-acetylgalactosamine (GalNAc)
- •15. History of intolerance to SC injection(s) or significant abdominal scarring that could potentially hinder study drug administration or evaluation of local tolerability
- •16. History of meningococcal infection within 12 months before screening
- •17. Known history or evidence of chronic liver disease, alcohol abuse or cirrhosis
- •18. Concomitant use of anticoagulants if not on a stable dose regimen for at least 2 weeks prior to screening
- •19. Significant aplasia e.g. neutrophils <0.5 x 10*9/l or platelets <30 x 10*9/l
研究者
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