ong-term Albumin administration in cirrhotic patients with ascites
- Conditions
- Subjects with decompensated cirrhosis and ascitesMedDRA version: 20.1Level: LLTClassification code 10064704Term: Decompensated cirrhosisSystem Organ Class: 100000004871Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2016-001789-28-DK
- Lead Sponsor
- Instituto Grifols S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 410
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effect of standard medical treatment (SMT) plus long-term Albutein 20% (SMT + Albutein 20%) administration on 1-year transplant-free survival versus SMT alone.;Secondary Objective: - To evaluate the effects of SMT + Albutein 20% administration on 3- and 6-month transplant-free and overall survival versus SMT alone<br><br>- To evaluate the effects of SMT + Albutein 20% administration on 1-year overall survival versus SMT alone<br><br>- To evaluate the total number of paracenteses and the incidence of refractory ascites according the International Club of Ascites (ICA) criteria;Primary end point(s): The primary efficacy endpoint is to compare the 1-year transplant-free survival in the intent-to-treat (ITT) population between the SMT + Albutein 20% treatment group and the SMT alone group.;Timepoint(s) of evaluation of this end point: 1 year
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary efficacy endpoints are to assess the effects of SMT + Albutein 20% treatment versus SMT alone on: 1) 3- and 6-month transplant-free and overall survival, 2) 1-year overall survival, and 3) total number of paracenteses and the incidence of refractory ascites.;Timepoint(s) of evaluation of this end point: 3 and 6 months and 1 year.