Albutein for Cirrhosis
(PRECIOSA Trial)

Recruiting in Palo Alto (17 mi)

+67 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Grifols Therapeutics LLC

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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 subjects with decompensated cirrhosis and ascites. The study population will consist of 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 acute-on-chronic liver failure (ACLF) at admission or during hospitalization but without ACLF at discharge.

Research Team

Eligibility Criteria

Adults with decompensated liver cirrhosis and ascites, not currently in acute-on-chronic liver failure (ACLF), can join this trial. They must have a CLIF-C AD score over 50 and be stable post-hospitalization for liver issues. Excluded are those with ACLF at screening, severe lung or heart conditions, recent other trials participation, active drug addiction (excluding alcohol/marijuana), ongoing infections like SBP or COVID-19, kidney failure, certain therapies like TIPS/shunts or dual antiplatelets/anticoagulants.

Inclusion Criteria

I have been diagnosed with liver cirrhosis.

CLIF-C AD score > 50 points at screening

I was hospitalized for a severe worsening of liver cirrhosis with fluid buildup.

See 5 more

Exclusion Criteria

I currently have an SBP infection.

I currently have COVID-19, am recovering, or show symptoms of it.

I have kidney disease with kidney failure.

See 19 more

Treatment Details

Interventions

Albutein 20% Injectable Solution (Albumin)

Trial OverviewThe study is testing the effectiveness of adding Albutein 20% Injectable Solution to standard medical treatment compared to standard treatment alone in managing decompensated cirrhosis and ascites. It's a phase 3 trial where participants are randomly assigned to one of the two groups.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard Medical Treatment + Albutein 20%Experimental Treatment2 Interventions

Standard Medical Treatment plus Albutein 20% administrations

Group II: Standard Medical TreatmentActive Control1 Intervention

The sites will follow the Standard Medical Treatment as per their Standard of Care.