NCT02200029已完成3 期
Open-Label Study With Ademetionine (Heptral®) in Subjects With Intrahepatic Cholestasis (IHC) Associated With Alcoholic Liver Disease (ALD)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 75
- 试验地点
- 12
- 主要终点
- Concentrations (Units per liter) of Alkaline phosphatase (ALP) or gamma-glutamyltransferase (γGT)
研究概览
简要总结
A research study of an approved drug called Heptral®, ademetionine, to treat adults with intrahepatic cholestasis (a condition where bile cannot flow from the liver to the duodenum) in pre-cirrhotic and cirrhotic states. Experience from clinical studies in subjects with liver disease has shown that ademetionine is effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Subjects with a known hypersensitivity to the active substance of ademetionine or to any of the inactive ingredients
- •Subjects with extrahepatic cause of cholestasis (proven by ultrasound or described in medical history)
- •Diagnosis of human immunodeficiency virus (HIV) in medical history
- •Subjects with chronic liver disease Child-Pugh class C
- •Subjects in the decompensation stage of ALD (such as Maddrey Score >32)
- •Subjects with primary sclerosing cholangitis (PSC)
- •Subjects with primary biliary cirrhosis (PBC)
- •Any form of malignancy within the past 5 years and/or basal cell carcinoma and squamous cell carcinoma of the skin within the past two years
- •Subjects with drug-induced liver disease
- •History of active substance abuse (oral, inhaled or injected) within one year prior to the study
- •Subjects with renal impairment (creatinine level of >2.0 mg/dL or > 150 µmol/l)
- •Subjects with known genetic defects affecting the methionine cycle and/or causing homocystinuria and/or hyperhomocysteinemia (e.g., cystathionine beta-synthase deficiency, Vitamin B12 metabolism defect) or known folate, Vitamin B6 or B12 deficiency
- •Subjects on total parenteral nutrition in the year prior to screening
- •Subjects after or planned for bariatric surgery (jejunoileal bypass or gastric weight loss surgery)
- •Subjects after liver transplantation and subjects on the waiting list for liver transplantation
- •Subjects with any of the following disease in medical history:
- •Viral hepatitis (serum positive HBcAb or Hepatitis C Virus (HCV) RNA)
- •Evidence of autoimmune liver disease
- •Wilson´s disease
- •Hemochromatosis
- •Alpha-1-antitrypsin deficiency
- •Subjects with history of biliary diversion
- •History of major depression or bipolar disease
- •Women of childbearing potential: positive urine pregnancy test during screening or unwillingness to use an effective form of birth control during the study.
- •Breastfeeding women
- •Any condition that, in the opinion of the investigator, does not justify the patient's inclusion into the study
- •Investigational drug intake within one month prior to the study
- •Active, serious medical disease other than ALD with likely life-expectancy less than five years
研究组 & 干预措施
Ademetionine IV
Experimental
干预措施: Ademetionine IV+tablet (Drug)
Ademetionine oral
Experimental
干预措施: Ademetionine tablet (Drug)
结局指标
主要结局
Concentrations (Units per liter) of Alkaline phosphatase (ALP) or gamma-glutamyltransferase (γGT)
时间窗: from baseline up to the end of treatment visit (56-60 days)
Improvement of ALP or γGT after 8 weeks of treatment with ademetionine compared to baseline
次要结局
- The intensity of clinical symptoms (jaundice, pruritus, fatigue and depressed mood) will be recorded for each symptom separately using six categories: No symptoms (0), minimum (1) to maximum (5).(At baseline and after 2 weeks IV treatment or after 4 weeks oral treatment and after 2 months treatment)
- Concentrations of ALP, γGT, Alanine Transaminase (ALT) and Aspartate aminotransferase (AST) (Units per liter) and of serum total and conjugated bilirubin (µmol per liter)(At baseline and after 2 weeks intravenously (IV) treatment or after 4 weeks oral treatment and after 2 months treatment)
- Evaluation of the responder rate by comparing concentrations at certain time points (units per liter) to baseline concentrations(At baseline and after 2 weeks IV treatment or after 4 weeks oral treatment and after 2 months treatment)
研究者
研究点 (12)
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