CTIS2023-504196-24-00招募中1 期
An Open-label, Randomized, Active-Controlled, Phase 3 Study of Setrusumab Compared With Bisphosphonates in Pediatric Subjects With Osteogenesis Imperfecta Types I, III or IV - UX143-CL314
ltragenyx Pharmaceutical Inc.0 个研究点目标入组 68 人开始时间: 2023年4月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 68
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
- 年龄范围
- 0 至 17（—）
- 性别
- All
入选标准
- •Male or female 2 to < 7 years of age at time of informed consent, Clinical diagnosis of OI Types I, III, or IV confirmed by identification of genetic mutation in COL1A1 or COL1A2, History of = 1 fracture in the past 12 months, = 2 fractures in the past 24 months, or = 1 femur, tibia, or humerus fracture in the past 24 months, Any prior exposure to, or currently receiving, IV-bisphosphonate therapy for treatment of OI, Serum 25-hydroxyvitamin D level = 20 ng/mL at the Screening visit. If 25- hydroxyvitamin D levels are below 20 ng/mL, the subject may be rescreened after a minimum of 14 days of vitamin D supplementation as directed by the Investigator
排除标准
- •Contraindication for the use of IV bisphosphonates based on clinical judgment of the Investigator, Prior treatment with growth hormone, denosumab, anti-sclerostin antibody, or other anabolic or anti-resorptive medications impacting the bone (other than bisphosphonates) at any time, History of external radiation therapy, Known hypersensitivity to setrusumab or its excipients that, in the judgment of the Investigator, places the subject at increased risk for adverse effects, Presence or history of any condition that, in the view of the Investigator, would interfere with participation, pose undue risk, or would confound interpretation of results, Use of any investigational product or investigational medical device within 4 weeks or 5 half-lives (whichever is longer) of investigational drug prior to Screening, or during the study (per discretion of the Investigator in consultation with the Medical Monitor), Concurrent participation in another clinical study without prior approval from the study Medical Monitor, History of skeletal malignancies or bone metastases at any time, History of neural foraminal stenosis (except if due to scoliosis), Clinical manifestations of Chiari malformation or basilar invagination. Presence of any other neurologic disease that has been clinically unstable within past 2 years requires review by the Medical Monitor., History of or current uncontrolled concomitant diseases that may impact bone metabolism, such as hypo/hyperparathyroidism, abnormal thyroid function, nephrotic syndrome, or Stage IV/V renal disease, Any skeletal condition (other than OI) leading to bone deformity and/or increased risk of fractures, such as rickets, osteopetrosis, idiopathic juvenile osteoporosis, or skeletal dysplasia, History of known cardiovascular disease such as coronary artery anomaly, Kawasaki disease, myocarditis, cardiomyopathy, myocardial infarction, stroke, or thromboembolic disease. Individuals with other congenital or acquired cardiovascular disease necessitating echocardiogram require Medical Monitor review. Investigators should consider whether the potential benefits of treatment outweigh the potential risks in patients with cardiovascular risk factors such as confirmed arterial hypertension., Hypocalcemia, defined as serum calcium levels below the age-adjusted normal limit reference ranges after a recommended = 4 hour fast, at Screening, Estimated glomerular filtration rate = 35 mL/min/1.73 m2 at Screening
研究者
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