Randomized Controlled Trial of Mycophenolate Mofetil Versus Steroid Therapy in Alcoholic Hepatitis.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the efficacy of MMF versus steroid therapy in improving short-term (28 day) survival outcomes in patients with alcoholic hepatitis
研究概览
简要总结
Study Design: Single-center, randomized control trial of 1 year duration.
Aim and Objective – To compare the efficacy and safety of Mycophenolate Mofetil (MMF) versus steroid therapy for the treatment of alcoholic hepatitis.
Hypothesis –
- MMF as a first line agent maybe associated with better 28 day and 90-day survival without increasing the risk of infection.
Study population: Patients > 18 years of age.Who are diagnosed as Alcoholic hepatitis based on NIAAA criteria.
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Study design: Randomized double blinded study.
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Study period: 1 year.
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Intervention: Intervention arm in the study will receive MMF at a dose of 750 mg twice daily for a period of 28 days, while the control arm will receive steroid at a dose of 40 mg for 28 days. However, based on Lille’s score the decision to continue or discontinue steroid will be taken. In case of discontinuation of the drug in either group, they will be provided best medical care and nutrition as salvage therapy.
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Monitoring and assessment: History of all patients with special emphasis to alcoholic history will be taken. The diagnosis of alcoholic hepatitis is confirmed by NIAAA criteria. Liver biopsy will be done in clinically indicated cases. Patients will be classified into acute on chronic liver disease (ACLF) based on APASL criteria. Patients who are eligible for steroid therapy will be randomized to receive steroid or MMF based on computer software. Patients who are in MMF group will receive 750 mg twice daily of MMF. Patients who are in steroid group will receive 40 mg Prednisolone. The study is open label randomized control trial. Lilles score is calculated at 5th day to see for response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults aged 18-70 years.
- •Diagnosis of Alcoholic hepatitis based on NIAAA criteria
- •MELD 20-35
- •Willing to follow up.
排除标准
- •Patients with hepatic/ extra hepatic malignancies
- •Patients with contraindications to steroids
- •Patients who are critically ill and are admitted to the ICU
- •Patient who have severe extra hepatic organ failure
- •Patients who are HBsAg +, HIV+
- •If female of childbearing potential: known pregnancy, or unwilling to practice anticontraceptive measures
- •Patients who are on current treatment with prednisone and/or immunosuppressive me.
结局指标
主要结局
To compare the efficacy of MMF versus steroid therapy in improving short-term (28 day) survival outcomes in patients with alcoholic hepatitis
时间窗: 28 days
次要结局
- To assess the impact of MMF versus steroid therapy on disease severity in patients with alcoholic hepatitis at 28 days and 90 days(28 & 90 days)
- To investigate the safety profile of MMF versus steroid therapy in patients with alcoholic hepatitis, including adverse events and tolerability.(28 & 90 days)
- To compare the efficacy of MMF versus steroid therapy in improving long-term (90 day) survival outcomes in patients with alcoholic hepatitis(28 & 90 days)
- To see molecular biomarkers like Interleukin (IL 6), Interleukin(IL 1) and their response to both the therapies.(28 & 90 days)
研究者
Dr Ananthu SJ Narayan
Institute of Liver and Biliary Sciences