Effects of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) on Short-term Survival in Subjects with Acute-On-Chronic Liver Failure" (ACLF) at High Risk of Hospital Mortality

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502187-20-00

Acronym

IG1407

Enrollment

266

Registered

2024-02-26

Start date

2019-04-11

Completion date

2025-04-14

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ACLF-2, or ACLF-3a detected either at admission or during hospitalization, Subjects with cirrhosis with ACLF-1b

Brief summary

The primary efficacy endpoint is to is to compare the 90-day overall survival in the intent-to-treat (ITT) population between the SMT+PE-A 5% treatment group and the SMT control group.

Detailed description

The secondary efficacy endpoints are to assess the effects of PE-A 5% on: 1) 90-day transplant-free survival and 2) 28-day overall survival versus SMT alone.

Interventions

DRUGAlbutein 50 g/l solución para perfusión.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is to is to compare the 90-day overall survival in the intent-to-treat (ITT) population between the SMT+PE-A 5% treatment group and the SMT control group.	—

Secondary

Measure	Time frame
The secondary efficacy endpoints are to assess the effects of PE-A 5% on: 1) 90-day transplant-free survival and 2) 28-day overall survival versus SMT alone.	—

Countries

Austria, Belgium, Bulgaria, Croatia, France, Germany, Hungary, Italy, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026