NL-OMON52183已完成不适用
A 2-Part, Phase 1, Multicenter, Single Dose, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CSL889 in Adult Patients with Sickle Cell Disease - CSL889_1001 (2102/0113)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
研究概览
简要总结
Trial is onging in other countries
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •Diagnosis of SCD as documented in the subject's medical record
- •Aged 18 to 60 years, inclusive
- •Stable SCD for at least 30 days before Day 1. Stable SCD is defined as the
- •subject being at his or her medical baseline, with no evidence of worsening of
- •disease over the last 30 days (including VOC, recent major surgery,
- •hospitalization, serious infection, significant bleeding, cerebrovascular
- •accident, seizures, or IV opioids)(Part A)
- •Uncomplicated VOC requiring parenteral opioid treatment and admission to
- •hospital for management
- •Uncomplicated VOC is defined as sickle cell pain without the following
- •associated clinical features (Part B):
- •o Fever (> 38.5 °C)
- •o Hypotension (< 90/60 mmHg)
- •o Hypoxia (< 90% oxygen saturation on room air, or requiring oxygen therapy to
- •maintain oxygen saturation above 90%)
- •o New neurological signs and / or symptoms clinically suggestive of stroke or
- •transient ischemic attack
- •o Signs and / or symptoms of Acute Chest Syndrome, accompanied by any new
- •pulmonary infiltrate on chest radiography (chest X-ray to be performed if
- •clinically indicated and according to local clinical guidelines)
- •Subject is either not taking one of the study permitted SCD therapies
- •(hydroxyurea, L-glutamine, L-glutaminecrizanlizumab, and/or voxelotor) or
- •subject has been taking one or more of those for at least 30 days before Day 1
- •and is on a stable, well tolerated regimen that is planned to continue without
- •change throughout the study
排除标准
- •History of primary hemorrhagic stroke
- •History or evidence of inherited bleeding diathesis or significant
- •coagulopathy at risk for bleeding
- •Hospitalization for vaso-occlusive crisis (VOC) or treated with parenteral
- •pain medications in other medical settings such as the emergency department or
- •day hospital for VOC during the past 30 days before Day 1
- •Blood transfusion within the 90 days before Day 1, or expecting blood
- •transfusion during the study
- •Weight >110 kg (242 lbs)
- •Surgery within 30 days before Day 1 or any preplanned surgeries during the
- •study (minor surgeries may be permitted under local anesthesia before
- •screening, with permission of the medical monitor)
- •Female subjects who are pregnant or breastfeeding
- •Female subject of childbearing potential or fertile male subject either not
- •using or not willing to use an acceptable method of contraception to avoid
- •pregnancy during the study and for 30 days after receipt of CSL889.
- •Treatment with any other drug / biologic that is newly approved for SCD
- •during the conduct of this study within 90 days before Day 1.
- •Exceptions: crizanlizumab [Adakveo®] and voxelotor [Oxbryta®] are permitted
- •(where prescribed).
- •Treatment with another investigational product within 30 days or within 5
- •half-lives of the product (whichever is greater) before Day 1
- •Vaccination within 30 days before Day 1, or planned vaccination during the
- •Body-mass index < 16 kg/m2 or weight < 50 kg (110 lbs)
- •History of anaphylactic-type reactions, transfusion related reaction, asthma,
- •or autoimmune disease
研究者
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