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 DILICORT clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 14
- 主要终点
- The proportion of patients that achieve a decrease of at least 50% of the peak value in TBL at day 14.
研究概览
简要总结
To assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased TBL, i.e., reduction of the peak of TBL by at least 50% at 14 days or reduction time to normalisation of TBL value. To assess if oral prednisone (compared to placebo) is safe and well tolerated in patients with acute moderate to severe DILI.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 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 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) ≥
- •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
结局指标
主要结局
The proportion of patients that achieve a decrease of at least 50% of the peak value in TBL at day 14.
The proportion of patients that achieve a decrease of at least 50% of the peak value in TBL at day 14.
Time (days) to TBL value return to normal.
Time (days) to TBL value return to normal.
Proportion of AEs, SAEs, fatality, and proportion of patients with premature termination due to AEs.
Proportion of AEs, SAEs, fatality, and proportion of patients with premature termination due to AEs.
次要结局
- The proportion of patients that achieve a decrease of at least 50% of the peak value in ALT, AST and INR at day 7.
- Time (days) for the ALT, AST and INR values return to normal.
- Proportion of patients that develop acute liver failure, need for liver transplantation or liver related death at day 28.
- Score changes in SF-36 quality of life validated questionnaire performed at visit 1 (day 1, start of treatment) and at visit 6 (day 35, end of treatment).
研究者
Rocío Moreno González and Elvira Bonilla Toyos
Scientific
Fundacion Publica Andaluza Para La Investigacion De Malaga En Biomedicina Y Salud