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Short-term Survival of Subjects With Acute-on-chronic Liver Failure After Plasma Exchange With Human Serum Albumin 5%

Short-term survival study on liver failure after plasma exchange treatment.

Recruiting
18-79 years
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is for people with acute-on-chronic liver failure (ACLF), which is when a person with existing liver damage suddenly gets much sicker. We want to see how a treatment called plasma exchange with human serum albumin 5% (PE-A 5%) works. In plasma exchange, some blood is removed, cleaned, and returned to the body. The study will compare two groups: one gets standard medical treatment (SMT) plus PE-A 5%, and the other gets SMT only. The study will take place at about 40 centers in the US, Canada, and Europe.

  • The treatment lasts from 7 to 17 days, depending on the patient's condition.
  • All participants will be checked for 90 days after treatment starts.
  • The study includes 380 people with ACLF, aged 18 to 79 years.

To be in the study, you must have certain types of ACLF and agree to participate. If you have other severe health issues or have been in another study recently, you might not be eligible. The study ensures patient safety with regular monitoring.

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Study details
    Acute-On-Chronic Liver Failure

NCT03702920

Grifols Therapeutics LLC

11 January 2025

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