Proof-of-concept Phase II Study to Evaluate the Efficacy and Safety of Prednisone in the Treatment of Idiosyncratic Hepatotoxicity and Its Mechanistic Pathways Through an Integrative Analysis: the DILI-CORT Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Total bilirubin
研究概览
简要总结
This trial´s aim is to assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased total bilirubin (TBL): reduction of the peak of TBL at least 50% at 14 days or reduction in the time to normalisation of TBL value.
详细描述
This trial´s aim is to assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased total bilirubin (TBL): reduction of the peak of TBL at least 50% at 14 days or reduction in the time to normalisation of TBL value, and to assess if oral prednisone (compared to placebo) is safe and well tolerated in patients with acute moderate to severe DILI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Prednisone medication and its placebo will be identical in appearance and in organoleptic properties.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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 times the Upper Limit of Normal (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.
- •DILI due to immune-checkpoint inhibitors.
- •Presence of active infection as evidenced by positive urine or blood culture.
- •Acute liver failure (international normalized ratio (INR) > 1.5 and hepatic encephalopathy).
- •Model for End-Stage Liver Disease (MELD) ≥
- •Known hypersensitivity to prednisone or placebo components.
- •Pregnant or nursing mothers.
- •Co-existing infection with hepatitis C, hepatitis B, or human immunodeficiency virus (HIV).
- •Patients already receiving systemic steroids or other immunosuppressants.
- •Inability to provide informed consent.
- •Presence of clinically significant comorbid illnesses (by clinician's criteria) that might impede the completion of the study.
研究组 & 干预措施
Active treatment
Oral prednisone
干预措施: Prednisone (Drug)
Placebo treatment
Placebo
干预措施: Prednisone (Drug)
结局指标
主要结局
Total bilirubin
时间窗: Through study completation, an average 2 years
To assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased total bilirubin (TBL): reduction of the peak of TBL at least 50% at 14 days or reduction in the time to normalisation of TBL value.
次要结局
- Aspartate aminotransferase level(2 years)
- International normalized ratio values(Through study completation, an average 2 years)
- Peak alanine aminotransferase level(2 years)