Comparing Efficacy and Tolerability of Cyclosporine-A vs. Prednisolone for Induction of Remission in Auto-immune Hepatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Remission
研究概览
简要总结
Untreated Autoimmune hepatitis (AIH) is a progressive disease. Mainstay of treatment are corticosteroids (CS). In addition to being ineffective a substantial minority of cases, corticosteroid side-effects hamper effective therapy in another subgroup. Alternative options for induction of remission are limited. There are reports of successful salvage therapy with Cyclosporine-A (CsA) in steroid refractory cases. In addition, open-labeled studies have shown efficacy of Cyclosporine-A in treatment-naive AIH patients. There are no studies comparing CsA and CS in a head to head trial. The investigators aim to assess the efficacy and tolerability of CsA directly to the CS for induction of remission in treatment-naive AIH patients.
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
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •16-65 years old individuals with probable of definite AIH according to the revised AIH criteria.
- •Willing and able to participate in the study
排除标准
- •Non-consenting patients
- •decompensated cirrhosis, i.e. clinical ascites, hepatic encephalopathy, history of variceal bleeding
- •Presence of serious concomitant cardiovascular, pulmonary or renal condition
- •Presence of active malignant disorder
研究组 & 干预措施
Group-A
Treatment-naive AIH patients consenting to participate
干预措施: Cyclosporine-A (Drug)
Group-B
Treatment-naive AIH patients consenting to participate. This group will receive Cyclosporine-A according to a set protocol.
干预措施: Cyclosporine-A (Drug)
结局指标
主要结局
Remission
时间窗: 12 months
AST/ALT less than 2x UNL No clinical symptom
Treatment failure
时间窗: 3 months
Failure to achieve AST/ALT less than 2x UNL despite adjusting dose according to protocol
次要结局
- Serious adverse event(12 months)
- Frequency of adverse events(12 months)
研究者
Siavosh Nasseri-Moghadam
MD, MPH, AGAF, Associate Professor of Medicine
Tehran University of Medical Sciences