EUCTR2015-002674-20-DE进行中（未招募）1 期
A Phase 2, Open-Label, Multiple Ascending Dose Study to Evaluate the Efficacy, Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of ALXN1210 Administered Intravenously to Patients with Paroxysmal Nocturnal Hemoglobinuria
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 26
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. Male or female patients = 18 years of age
- •2. PNH diagnosis confirmed by documented high-sensitivity flow cytometry (red blood cells [RBCs] and/or granulocytes)
- •3. Mean lactate dehydrogenase (LDH) =3 × upper limit of normal, based on 2 measurements from separate blood samples collected at least 1 day apart during screening
- •4. Willing and able to give written informed consent and comply with the study visit schedule
- •5. Documented meningococcal vaccination not more than 3 years prior to dosing
- •6. Female patients who consider themselves postmenopausal must provide evidence at screening of menopause status, based on a combination of amenorrhea for at least 1 year and increased serum follicle-stimulating hormone level (> 30 IU/L) on at least 2 occasions (eg, in the absence of hormone replacement therapy, dietary phytoestrogens) or estradiol concentration < 10 pg/mL.
- •7. Female patients of childbearing potential must use highly effective contraception as defined below, starting at screening and continuing until at least 8 months after the last dose of ALXN1210.
- •8. Male patients with a female spouse/partner of childbearing potential or a pregnant or breastfeeding spouse or partner must agree to use barrier contraception (male condom) during the Treatment Period and for at least 8 months after the last dose of ALXN1210. Barrier contraception is required even with documented medical assessment of surgical success of a vasectomy. Female spouses/partners of male patients who are of childbearing potential must use highly effective contraception or acceptable contraception, as defined below, starting at screening and continuing until at least 8 months after the last dose of ALXN1210. Male patients must not donate sperm during the
- •Screening and Treatment Periods and for at least 8 months after the last dose of ALXN1210.
- •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 22
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 4
排除标准
- •1. Treatment with a complement inhibitor at any time
- •2. Platelet count < 30,000/mm3 (30 × 109 /L) at screening
- •3. Absolute neutrophil count < 500/µL (0.5 × 109 /L) at screening
- •4. History of bone marrow transplantation
- •5. History of Neisseria meningitidis infection or history of unexplained, recurrent infection;
- •6. Female patients who are planning to become pregnant, or are pregnant or breastfeeding
研究者
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