A Phase IB, Randomized, Placebo-Controlled Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Crovalimab for the Management of Acute Uncomplicated Vaso-Occlusive Episodes (VOE) in Patients With Sickle Cell Disease (SCD) - BO42452

F. Hoffmann-La Roche AG0 个研究点目标入组 53 人开始时间: 2023年6月16日最近更新: 2024年8月21日

适应症

试验速览

暂无简介。

•Body weight >=40 kg, Confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSß0 (SCD genotype of sickle cell beta zero thalassemia), Vaccination against Neisseria Meningitidis,, and vaccinations against H. influenzae type B and S. pneumoniae, Diagnosis of an acute uncomplicated VOE that requires admission to a hospital/acute medical facility and treatment with parenteral opioid analgesics, Adequate hepatic and renal function, Participants receiving sickle cell therapies must be on a stable dose for >=28 days

•More than 10 VOEs within the last 12 months prior to presentation that have required a medical facility visit, Pain related to the current VOE ongoing for >48 hours, Acute pain related to avascular necrosis, hepatic or splenic sequestration, or priapism, and pain atypical of an acute uncomplicated VOE, Transfusion or receipt of blood products within 3 months or current participation in a chronic transfusion protocol, Known or suspected hereditary complement deficiency, Pregnant or breastfeeding, or intending to become pregnant during the study or within 322 days (approximately 10.5 months) after the study drug administration

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