ong-term Albumin administration in cirrhotic patients with ascites
- Conditions
- Subjects with decompensated cirrhosis and ascitesTherapeutic area: Diseases [C] - Digestive System Diseases [C06]MedDRA version: 20.0Level: LLTClassification code 10064704Term: Decompensated cirrhosisSystem Organ Class: 100000004871
- Registration Number
- EUCTR2016-001789-28-ES
- Lead Sponsor
- Instituto Grifols S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 410
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
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.
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.