EUCTR2016-001789-28-DE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.
- •2v5. Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).
- •3v5. Subjects who have been hospitalized 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 Screening.
- •4v5. This criterion has been removed from Version 5 of the protocol.
- •5. In subjects with cirrhosis due to HBV, decompensation must occur in the setting of continuous (no less than 3 months) appropriate antiviral
- •6. In subjects with cirrhosis due to HCV, only decompensated patients who will not receive antiviral therapy during the study period will be
- •included (subjects receiving antiviral therapy within 14 days prior to enrollment cannot be included in the study).
- •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.
- •9v5. CLIF-C score > 50 points at screening.
- •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
- •1v5. Subjects with ACLF at Screening.
- •2v5. Subjects with type 1 HRS currently on treatment with vasoconstrictors or hemodialysis.
- •3. Subjects with TIPS or other surgical porto-caval shunts.
- •4v5. Subject with refractory ascites as defined by ICA criteria without any other event of acute decompensation (Appendix 2).
- •5v5. This criterion has been removed from protocol Version 5.
- •6v5. Subjects receiving dual anti-platelet therapy or anti-coagulant therapy (exception: DVT prophylaxis).
- •7v5. Subjects with ongoing endoscopic eradication of esophageal varices with =2 endoscopic sessions completed before screening.
- •8v5. This criterion has been removed from protocol Version 5.
- •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] [Appendix 6], non-melanocytic skin cancer, or controlled breast or prostate cancer can be included.
- •10v4. Subjects with acute or chronic heart failure (New York Heart Association [NYHA] Appendix 7).
- •11. Subjects with severe (grade III or IV) pulmonary disease (Global Obstructive Lung Disease [GOLD] Appendix 8).
- •12v5. Subjects with nephropathy with renal failure with a serum creatinine >2 mg/dL or systemic hypertension.
- •13v5. This criterion has been removed from protocol Version 5.
- •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
- •16. Females who are pregnant, breastfeeding, or, if of childbearing potential, unwilling to practice effective methods of contraception (oral,
- •injectable, or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system, condom, or
- •occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence*) throughout the study. * True abstinence: When this is in line with the preferred and usual lifestyle of the subject (periodic abstinence [eg, calendar, ovulation, symptothermal, postovulation methods], declaration of abstinence for the duration of the clinical study, and withdrawal are not acceptable methods 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.
- •20v4. Subjects with active drug addiction (exceptions: active alcoholism or marijuana)
- •21. In the opinion of the investigator, the subject may have compliance problems with the protocol and the procedures of the protocol.
- •22. Subjects with ongoing or recent variceal bleeding. (subjects can be included 2 weeks after hemorrhagic episode).
- •23. Subjects with septic shock at screening.
- •24. Subjects with ongoing SBP infection (subjects can be included upon resolution).
- •25. Subjects with current infection of COVID19, those who are less than 14 days post recovery, or those who have clinical signs and symptoms consistent with COVID19 infection.
研究者
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