CTIS2023-504756-96-00进行中（未招募）1 期
Therapeutic approach in Colchicine-resistant Recurrent pEricarditis in children: an open-label randomized trial comparing Anakinra vs sTEroids - The CREATE Trial
Giannina Gaslini Institute For Scientific Hospitalization And Care0 个研究点目标入组 48 人开始时间: 2023年3月31日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 48
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 and female patients, from 8 months to less than 18 years, Parent or legal guardian written informed consent and child assent, if appropriate, are required before any assessment is performed, Diagnosis of relapse of pericarditis in a patient with previous diagnosis of acute pericarditis (idiopathic or secondary to invasive cardiac procedures), Inadequate response or intolerance to non-steroidal anti-inflammatory drugs or colchicine
排除标准
- •Pericarditis secondary to a known infection (viral, bacterial, mycobacterial), Any conditions or significant medical problems, which in the opinion of the investigator places the patient at unacceptable risk for immunomodulatory therapy, Main alteration in the blood count: Neutropenia (absolute neutrophil count <1000/mmc), Thrombocytopenia (platelets <100.000/mmc) or Severe anaemia (Hb < 7.5 mg/dl), Presence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B or Hepatitis C infections, Evidence of active or latent tuberculosis (TB) determined by positive QuantiFERON (QFT-TB G In-Tube) test or positive Purified Protein Derivative (PPD) test (>5 mm induration) within 2 months prior to randomization, Presence of laboratory or echocardiographic findings of myopericarditis, Administration of any investigational drug or implantation of investigational device, or participation in another trial, within 30 days before screening, Use of steroids at the dosage of 1 mg/kg/day of prednisone or equivalent for at least 5 days in the 30 days before randomization, Live vaccinations within 1 months prior to the start of the trial and during the trial, Pregnancy, confirmed by a positive hCG laboratory test, Female adolescents (<18 years of age) of childbearing potential who do not agree to abstinence or, if sexually active, do not agree to the use of contraception, Pericarditis in a patient with a previous diagnosis of any neoplasm and without complete recovery from at least one year, Patients fulfilling diagnostic criteria for an autoimmune systemic disease, Patients with a previous diagnosis of a genetically confirmed autoinflammatory disease
研究者
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