NCT01430429终止2 期
An Open Label Single Arm Study to Investigate the Safety and Efficacy of Multiple Administrations of NI-0801, a Fully Human Anti-CXCL10 Monoclonal Antibody in PBC Patients With an Incomplete Response to Ursodeoxycholic Acid
Light Chain Bioscience - Novimmune SA2 个研究点 分布在 2 个国家开始时间: 2011年9月8日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 试验地点
- 2
研究概览
简要总结
The purpose of the study is to assess safety and efficacy of multiple doses of NI-0801 in primary biliary cirrhosis patients with an inadequate response to ursodeoxycholic acid.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Proven primary biliary cirrhosis (PBC), as demonstrated by the presence of at least 2 of the following 3 diagnostic factor (History of increased alkaline phosphatase levels for at least 6 months; positive serum AMA titer; Liver biopsy consistent with PBC)
- •Elevated liver enzyme levels at screening
- •Have given written informed consent
排除标准
- •Screening bilirubin > 2.9 mg/dL (50 μmol/L)
- •Screening creatinine clearance < 80 ml/min
- •History or presence of hepatic decompensation (e.g., esophageal variceal bleeding, hepatic encephalopathy, or ascites)
- •Positive serology result for Human Immunodeficiency Virus (HIV), Hepatitis B or C
- •Known or previous diagnosis of malignancy
- •Presence of any active infection
- •Previous history of active TB within 12 months of screening
研究组 & 干预措施
NI-0801
Experimental
干预措施: NI-0801 (Drug)
研究者
研究点 (2)
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