Phase 4, Single-Arm Study of Ravulizumab in Adult Participants with Paroxysmal Nocturnal Hemoglobinuria Currently Treated with High-Dose Eculizumab - ALXN1210-PNH-401

Alexion Pharmaceuticals Inc.0 个研究点目标入组 20 人开始时间: 2020年3月17日最近更新: 2020年6月15日

试验速览

暂无简介。

•Participant must be 18 years of age or older, at the time of signing the
•informed consent.
•Documented diagnosis of PNH.
•Received 1200 mg eculizumab every 12 to 16 days (q2w) for at least 3 months prior to Screening.
•Lactate dehydrogenase (LDH) = 2 x upper limit of normal (ULN).
•Vaccinated against meningococcal infections within 3 years prior to, initiating study drug.
•Body weight = 40 kg.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range 0

•History of major adverse vascular events (MAVEs) within 6 months of Day 1.
•History of bone marrow transplantation.
•N. meningitidis infection: Participants with unresolved N. meningitidis infection at treatment initiation, Participants who are not currently vaccinated against N. meningitidis unless they receive prophylactic treatment with appropriate antibiotics until 2 weeks after vaccination.
•History of unexplained, recurrent infection.
•Active systemic bacterial, viral, or fungal infection within 14 days prior to study drug administration on Day 1.
•Concomitant use of anticoagulants is prohibited if not on a stable regimen for at least 2 weeks prior to Day 1.
•More than one LDH value > 2 × ULN within the 6 months prior to Day 1.
•Platelet count < 30,000/mm3 (30 × 109/L) at Screening.

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