NL-OMON48945撤回2 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) - CVAY736B2201 (AMBER)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- ovartis
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- AIH diagnosed per International Autoimmune Hepatitis Group
- •- Liver biopsy with Ishak modified HAI score equal or above 5
- •- Incomplete response to OR intolerance of standard therapy (per AASLD)
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
研究者
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