CTRI/2023/02/049717招募中2 期
A Phase II, Open-Label Study of NM8074 in Patients with Paroxysmal Nocturnal Hemoglobinuria(PNH)
ovelMed Therapeutics0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
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. Patients = 18 years (males and females), weight = 45 kg at the time of consent.
- •2. Confirmation of PNH diagnosis by flow cytometry evaluation white blood cells (WBCs), with neutrophil, granulocyte and/or monocyte clone size of =10%.
- •3. Evidence of ongoing hemolysis.
- •4. =1 pRBC transfusion within 12 months prior to screening.
- •5. Anemia (Hemoglobin =10.5 g/dL).
- •6. Lactate dehydrogenase (LDH) level = 1.5 times the upper limit of normal (xULN) during Screening.
- •7. All patients must be vaccinated prior to dosing with MenACWY Menactra® polysaccharide diphtheria toxoid conjugate vaccination against Neisseria meningitidis serogroups A, C, Y, and W-135 and MenB meningococcal serogroup B vaccine (Bexsero®). If the window of vaccination is short, then patients will be prophylactically treated with appropriate antibiotics.
- •8. Willing and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and comply with the study visit schedule.
排除标准
- •1. History of bone marrow, hematopoietic stem cell, or solid organ transplantation
- •2. History of splenectomy
- •3. Participation in any other investigational drug trial within 5 elimination half-lives of enrollment, or within 30 days, whichever is longer
- •4. Subjects currently or previously under other complement inhibitor treatments less than 3 months prior to study Day 1
- •5. Participants with known or suspected hereditary or acquired complement deficiency
- •6. History of currently active primary or secondary immunodeficiency
- •7. Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection within 2 weeks prior to first dose, or history of unexplained, recurrent bacterial infections
- •8. Has a known history of meningococcal disease or N. meningitidis infection
- •9. Patients on immunosuppressive agents or systemic corticosteroids less than 8 weeks prior to dosing
- •10. Known medical or psychological condition(s) or risk factor that, in the opinion of the Investigator, might interfere with the patient’s full participation in the study, pose any additional risk for the patient, or confound the assessment of the patient or outcome of the study.
- •11. Severe concurrent co-morbidities not amenable to active treatment, e.g., patients with severe kidney disease (CKD stage 4, dialysis)
- •12. Subjects currently or previously under other complement inhibitor treatments less than 3 months prior to study Day 1.
- •13. Pregnant, planning to become pregnant, or nursing female subjects. Female partners of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for 1 week after stopping the investigational drug.
- •14. Females who have a positive pregnancy test result at Screening or on Day 1.
- •15. Male patients and partners of child-bearing potential must agree to use contraceptives and male patients must agree to refrain from donating sperm for the duration of the study.
研究者
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