Efficacy and Safety of Budesonide Capsules (3x3mg/d)Versus Prednisone in Patients With a Diagnose of Active Autoimmune Hepatitis. A Double-blind, Randomized, Active-controlled, Multicentre Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Biochemical remission (=serum levels of ASAT and ALAT within normal ranges) at the individual last visit of Segment A and lack of steroid specific side effects
研究概览
简要总结
This is a multicentre, multinational clinical study. It comprised two consecutive segments (A and B). Segment A was designed as a randomized, double-blind, double-dummy, active-controlled, two-arm parallel-group study. The patients received either budesonide or prednisone for 6 months. During segment B all patients received budesonide as an open treatment for additional 6 months.
In this confirmatory study the proportion of patients with complete response was compared between the two treatment groups. Complete response was defined as biochemical remission (=serum levels of ASAT and ALAT within normal ranges) at the individual last visit of segment A and lack of steroid specific side effects throughout segment A.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 10 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 10 to 70 years
- •Diagnosis of acute AIH according to Alvarez score
- •normal range of TPMT activity
- •normal ACTH test
- •negative pregnancy test at screening for females of childbearing potential
- •written informed consent
排除标准
- •presence of Hepatitis A, B, C, E or G virus infection
- •liver cirrhosis or clinical signs of portal hypertension
- •history of hypersensitivity to the study medication
研究组 & 干预措施
budesonide
3mg capsules 3x/day for 6 months
干预措施: budesonide (Drug)
prednisone
5mg tablet, 40mg starting dose titrated to 10mg over 3 months
干预措施: prednisone (Drug)
结局指标
主要结局
Biochemical remission (=serum levels of ASAT and ALAT within normal ranges) at the individual last visit of Segment A and lack of steroid specific side effects
时间窗: 6 months
次要结局
- incidence of biochemical remission(6 months)