EUCTR2016-001789-28-BE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 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 (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 infection.
- •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
相似试验
进行中（未招募）
1 期
ong-term Albumin administration in cirrhotic patients with ascitesSubjects with decompensated cirrhosis and ascitesMedDRA version: 20.1Level: LLTClassification code 10064704Term: Decompensated cirrhosisSystem Organ Class: 100000004871EUCTR2016-001789-28-ITINSTITUTO GRIFOLS, S.A.410
进行中（未招募）
1 期
ong-term Albumin administration in cirrhotic patients with ascitesEUCTR2016-001789-28-FRInstituto Grifols S.A.410
进行中（未招募）
1 期
ong-term Albumin administration in cirrhotic patients with ascitesSubjects with decompensated cirrhosis and ascitesMedDRA version: 20.1Level: LLTClassification code 10064704Term: Decompensated cirrhosisSystem Organ Class: 100000004871EUCTR2016-001789-28-DEInstituto Grifols S.A.410
进行中（未招募）
1 期
ong-term Albumin administration in cirrhotic patients with ascitesEUCTR2016-001789-28-PLInstituto Grifols S.A.410
进行中（未招募）
1 期
ong-term Albumin administration in cirrhotic patients with ascitesSubjects with decompensated cirrhosis and ascitesMedDRA version: 20.1Level: LLTClassification code 10064704Term: Decompensated cirrhosisSystem Organ Class: 100000004871EUCTR2016-001789-28-DKInstituto Grifols S.A.410