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

NCT03451292 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 410

Last updated 2025-06-06

Study results available
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Summary

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.

Conditions

  • Decompensated Cirrhosis and Ascites

Interventions

DRUG

Albutein 20%

Injectable solution

OTHER

SMT

Participants received SMT according to institution standards for the management of decompensated cirrhosis.

Sponsors & Collaborators

  • Instituto Grifols, S.A.

    collaborator INDUSTRY

  • Grifols Therapeutics LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2024-05-21
Completion
2024-05-21
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Bosnia and Herzegovina
  • Bulgaria
  • Canada
  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Serbia
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03451292 on ClinicalTrials.gov