CTIS2024-513004-33-00进行中（未招募）1 期
Proof-of-concept Phase II study to evaluate the efficacy and safety of prednisone in the treatment ofidiosyncratic hepatotoxicity and its mechanistic pathways through an integrative analysis: the DILICORT clinical trial - DILICORT-2024
Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud0 个研究点目标入组 60 人开始时间: 2024年3月22日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- 18 至 65+（—）
- 性别
- All
入选标准
- •Female and male patients, aged = 18 years, Patients who have been diagnosed with DILI by the expert committee, Patients with moderate to severe DILI (elevations of ALT or AST = 5 x ULN and serum TBL = 2.5 mg/dL., Patients who do not show a 15% reduction in ALT values or TBL continues to increase 5-10 days after liver damage recognition despite the withdrawal of the culprit drug.
排除标准
- •No clear DILI diagnosis after an expert committee DILI assessment., Inability to provide informed consent, Presence of clinically significant comorbid illnesses (by clinician’s criteria) that might impede completion of the study., DILI due to immune-checkpoint inhibitors, Presence of active infection as evidenced by positive urine or blood culture., Acute liver failure (INR > 1.5 and hepatic encephalopathy), Model for End-Stage Liver Disease (MELD) = 30., Known hypersensitivity to prednisone or placebo components, Pregnant or nursing mothers, Co-existing infection with hepatitis C, hepatitis B, or HIV, Patients already receiving systemic steroids or other immunosuppressants
研究者
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