NL-OMON47216已完成2 期
An open, non-randomized, parallel-group pharmokinetic and -dynamic, investigator-initiated study on effects of obeticholic acid (OCA) in bile of patients with primary biliary cholangitis (PBC) and non-alcoholic steatohepatitis (NASH) in comparison to healthy controls - OCABILE
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 33
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 64（—）
入选标准
- •- Male or female patients / volunteers of 18 to 75 years of age.
- •- Body mass index within 18 to 40 kg/m2
- •- Positive AMA (anti-mitochondrial antibody) testing (for PBC patients).
- •- Proven non-cirrhotic liver disease compatible with PBC stage I, II, III or NASH, no reliable signs of portal hypertension such as esophageal varices or ascites and/or pylephlebectasia > 15 mm, and a fibroscan < 15 kPa.
- •- The diagnosis of NASH must be confirmed by a liver biopsy (e.g. according Brunt criteria) in the last 24 months
排除标准
- •- Existing cardiac / hematological / renal / gastrointestinal diseases which might interfere with the drugs' safety, tolerability, absorption, pharmacokinetics and / or endoscopy.
- •- Other acute or chronic diseases which might affect absorption or metabolism of OCA
- •- Existing disorders of the coagulation system or treatment with anticoagulants or agents inhibiting thrombocyte aggregation
- •- Positive anti-HIV-test, HBsAg-test or anti-HCV-test.
- •- Acute inflammation of the gallbladder.
- •- Cholecystectomy
- •- Histologically proven cirrhotic liver disease or total bilirubin > 2 mg/dl or reliable signs of portal hypertension such as esophageal varices or ascites and/or pylephlebectasia > 15 mm and / or fibroscan > 15 kPa.
研究者
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