Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites (PRECIOSA)

Grifols

Status and phase: Completed; Phase 3

Conditions: Decompensated Cirrhosis and Ascites

Treatments: Drug: Albutein 20%; Other: SMT

Study type: Interventional

Funder types: Industry

Identifiers

NCT03451292

2016-001789-28 (EudraCT Number)

IG1601

Details and patient eligibility

About

This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in participants with decompensated cirrhosis and ascites. The study population will consist of participants being discharged after hospitalization for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without acute-on-chronic liver failure (ACLF) at admission or during hospitalization but without ACLF at discharge.

Enrollment: 410 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female participants ≥18 years of age.
• Participants with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).
• Participants 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.
• In participants with cirrhosis due to hepatitis B virus, decompensation must occur in the setting of continuous (no less than 3 months) appropriate antiviral therapy.
• In participants with cirrhosis due to hepatitis C virus, only decompensated participants who will not receive antiviral therapy during the study period will be included (Participants receiving antiviral therapy within 14 days prior to enrollment cannot be included in the study).
• In participants with cirrhosis due to autoimmune hepatitis, decompensation must occur in the setting of continuous immunosuppressive therapy.
• Participants 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 participant in accordance with local law and institutional policy.
• Chronic liver failure-consortium acute decompensation (CLIF-C AD) score > 50 points at screening.

Exclusion criteria

• Participants with ACLF at Screening
• Participants with type 1 hepatorenal syndrome (HRS) currently on treatment with vasoconstrictors or hemodialysis.
• Participants with transjugular intrahepatic portosystemic shunt (TIPS) or other surgical porto-caval shunts.
• Participants with refractory ascites as defined by the International Club of Ascites (ICA) criteria without any other event of acute decompensation.
• Participants receiving dual anti-platelet therapy or anti-coagulant therapy (exception: deep vein thrombosis (DVT) prophylaxis).
• Participants with ongoing endoscopic eradication of esophageal varices with ≤ 2 endoscopic sessions completed before screening.
• Participants with evidence of current locally advanced or metastatic malignancy.
• Participants with acute or chronic heart failure (New York Heart Association [NYHA]).
• Participants with severe (grade III or IV) pulmonary disease (Global Obstructive Lung Disease [GOLD]).
• Participants with nephropathy with renal failure with serum creatinine >2 milligrams/deciliters (mg/dL) or systemic hypertension.
• Participants with severe psychiatric disorders.
• Participants with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection.
• Females who are pregnant, breastfeeding, or if of childbearing potential, unwilling to practice effective methods of contraception
• Participants with previous liver transplantation.
• Participants with known or suspected hypersensitivity to albumin.
• Participants participating in another clinical study within 3 months prior to screening.
• Participants with active drug addiction (exceptions: active alcoholism or marijuana).
• In the opinion of the investigator, the participants may have compliance problems with the protocol and the procedures of the protocol.
• Participants with ongoing or recent variceal bleeding (participants can be included 2 weeks after hemorrhagic episode).
• Participants with septic shock at screening.
• Participants with ongoing spontaneous bacterial peritonitis (SBP) infection (participants can be included upon resolution).
• Participants with current infection of coronavirus disease of 2019 (COVID19), those who are less than 14 days post recovery, or those who have clinical signs and symptoms consistent with COVID19 infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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410 participants in 2 patient groups

SMT + Albutein 20%

Experimental group

Description:

Participants received Albutein 20%, at a dose of 1.5 grams/kilograms (g/kg), based on their body weight (maximum 100 grams per participant), as an intravenous (IV) infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with standard medical treatment (SMT) administered as per institution standards for the management of decompensated cirrhosis up to 12 months.

Treatment:

Other: SMT

Drug: Albutein 20%

SMT

Active Comparator group

Description:

Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis.

Treatment:

Other: SMT