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Albumin

Albutein for Cirrhosis (PRECIOSA Trial)

Phase 3
Waitlist Available
Research Sponsored by Grifols Therapeutics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with diagnosis of liver cirrhosis
Subjects who have been hospitalized for acute decompensation of liver cirrhosis with ascites
Must not have
Subjects with ongoing SBP infection
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the standard treatment for decompensated cirrhosis plus Albutein to standard treatment alone, in order to evaluate the efficacy of Albutein.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects include allergic reactions to albumin for those sensitive to it. Since specific side effects aren't listed here, general risks may involve discomfort at injection sites and possible interactions with existing medications.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with liver cirrhosis.
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I was hospitalized for a severe worsening of liver cirrhosis with fluid buildup.
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I have worsening cirrhosis from hepatitis C and won't get antiviral therapy during the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I currently have an SBP infection.
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I currently have COVID-19, am recovering, or show symptoms of it.
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I have kidney disease with kidney failure.
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I have a TIPS or another type of liver shunt.
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I am experiencing septic shock.
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My cancer has spread beyond its original location.
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I am being treated for type 1 HRS with vasoconstrictors or hemodialysis.
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I am on blood thinner medication.
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I have heart failure.
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I have a severe lung condition.
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I am HIV positive.
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I have had recent bleeding from enlarged veins.
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I have severe fluid buildup in my abdomen not responding to treatment, without other complications.
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I am not pregnant, breastfeeding, and if able to have children, I agree to use contraception.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Albumin human
FDA approved

Find a Location

Who is running the clinical trial?

Grifols Therapeutics LLCLead Sponsor
58 Previous Clinical Trials
5,698 Total Patients Enrolled
Instituto Grifols, S.A.Industry Sponsor
29 Previous Clinical Trials
3,795 Total Patients Enrolled

Media Library

Albutein 20% Injectable Solution (Albumin) Clinical Trial Eligibility Overview. Trial Name: NCT03451292 — Phase 3
Cirrhosis Research Study Groups: Standard Medical Treatment + Albutein 20%, Standard Medical Treatment
Cirrhosis Clinical Trial 2023: Albutein 20% Injectable Solution Highlights & Side Effects. Trial Name: NCT03451292 — Phase 3
Albutein 20% Injectable Solution (Albumin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03451292 — Phase 3
~57 spots leftby Nov 2025
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