EUCTR2016-001789-28-IT进行中（未招募）1 期
Prevention of Mortality with Long-Term Administration of Human Albumin in Subjects with Decompensated Cirrhosis and Ascites - PRECIOSA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 410
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
- •1. Male or female subject =18 years of age.
- •2. Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology) and uncomplicated ascites according to the ICA criteria.
- •3. Subjects being discharged after hospitalization for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without ACLF at admission or during hospitalization but without ACLF at discharge.
- •4. Subjects with ongoing diuretic treatment with an anti-mineralocorticoid drug at a dose of =100 mg/day and furosemide =40 mg/day independent of response to treatment.
- •5. In subjects with cirrhosis due to HBV, decompensation must occur in the setting of continuous (not <3 months) appropriate antiviral therapy.
- •6. In subjects with cirrhosis due to HCV, only decompensated patients who will not receive antiviral therapy during the study period will be included.
- •7. In subjects with cirrhosis due to autoimmune hepatitis, decompensation must occur in the setting of continuous immunosuppressive therapy.
- •8. Subjects must be willing and able to provide written informed consent or have an authorized representative able to provide written informed consent on behalf of the subject in accordance with local law and institutional policy.
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •1. Subjects with ongoing ACLF at discharge.
- •2. Subjects with ongoing or recent (within the last 30 days) HRS, infection, or bleeding complications.
- •3. Subjects with TIPS or other surgical porto-caval shunts.
- •4. Subject with an established diagnosis of refractory ascites as defined by ICA criteria.
- •5. Subjects requiring =2 paracenteses during the previous 30 days.
- •6. Subjects receiving anti-platelet therapy or anti-coagulant therapy during the previous 30 days.
- •7. Subjects with ongoing endoscopic eradication of esophageal varices at discharge.
- •8. Subjects with HE grade III or IV.
- •9. Subjects with evidence of current locally advanced or metastatic malignancy. Subjects with hepatocellular carcinoma within the Milan criteria [1 nodule =5 cm or 3 nodules =3 cm]], non-melanocytic skin cancer, or controlled breast or prostate cancer can be included.
- •10. Subjects with chronic heart failure (New York Heart Association [NYHA]).
- •11. Subjects with severe (grade III or IV) pulmonary disease (Global Obstructive Lung Disease [GOLD]).
- •12. Subjects with serum creatinine >2.0 × upper limit of normal ([ULN] based on local laboratory results obtained prior to discharge).
- •13. Subjects with organic nephropathy as defined by ICA criteria.
- •14. Subjects with severe psychiatric disorders.
- •15. Subjects with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection.
- •16. Females who are pregnant, breastfeeding, or, if of childbearing potential, unwilling to practice a highly effective method of contraception.
- •17. Subjects with previous liver transplantation.
- •18. Subjects with known or suspected hypersensitivity to albumin.
- •19. Subjects participating in another clinical study within 3 months prior to screening.
- •20. Subjects with active drug addiction.
- •21. In the opinion of the investigator, the subject may have compliance problems with the protocol and the procedures of the protocol.
研究者
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