EUCTR2017-001555-32-BE进行中（未招募）1 期
A two-part randomized, double-blind, placebo-controlled multicenter dose ranging and confirmatory study to assess the safety and efficacy of VAY736 in autoimmune hepatitis patients with incomplete response to or intolerance of standard therapy (AMBER). - AMBER
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- AIH diagnosed per International Autoimmune Hepatitis Group
- •- Liver biopsy with Ishak modified HAI indicating active AIH
- •- Incomplete response to OR intolerance of standard therapy (per AASLD)
- •Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Prior use of any B-cell depleting therapy
- •- Required regular use of medications with known hepatotoxicity
- •- Decompensated cirrhosis
- •- Diagnosis of overlap syndrome with AIH (e.g., AIH+PBC, AIH+PSC)
- •- Drug related AIH at screening or a history of drug related AIH
- •- History of drug abuse or unhealthy alcohol use
- •- History of malignancy of any organ system
- •- Pregnant or nursing (lactating) women
- •- Other protocol-defined exclusion criteria may apply
研究者
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