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

Overview

About this study

The purpose of this study is to evaluate the effects of plasma exchange using human serum albumin 5% (PE-A 5%) in acute-on-chronic liver failure (ACLF) subjects.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female cirrhotic subjects.
  • Between 18 and 79 years of age.
  • Subjects with ACLF-1b, ACLF-2, or ACLF-3a detected either at admission or during hospitalization (must be ACLF-1b, -2, or -3a within the Screening Period [a maximum of 10 days]).
  • Willing and able to provide written informed consent or have an authorized representative able to provide written informed consent on behalf of the subject in accordance with local law and institutional policy.
  • In case of HE, informed consent will be provided by a relative or a legally authorized representative (surrogate).

Exclusion Criteria: 

  • Subjects without ACLF.
  • Subjects with ACLF-1a or ACLF-3b after the Screening Period.
  • Subjects fulfilling inclusion criteria that improve to no ACLF or to ACLF-1a or worsen to ACLF-3b during the Screening Period (between initial evaluation and time of randomization).
  • Subjects with ACLF for more than 10 days prior to randomization.
  • Subjects with acute or subacute liver failure without underlying cirrhosis.
  • Subjects with septic shock lasting >1 hour that does not respond to fluid resuscitation-IV therapy or pharmacologic-pressors.
  • Subjects with active bacterial or fungal infection with hemodynamic instability.
  • Subjects with acute respiratory distress syndrome (ARDS) with peripheral oxygen saturation (SpO^2) ≤89.
  • Subjects with active or recent bleeding (unless controlled for > 48 hours).
  • Subjects with severe thrombocytopenia (≤ 20×10^9/L) (based on local laboratory assessment).
  • Subjects with chronic renal failure and currently receiving hemodialysis.
  • Evidence of current locally advanced or metastatic malignancy. Subjects with hepatocellular carcinoma within the Milan criteria (1 nodule ≤ 5 cm or 3 nodules ≤ 3 cm), non-melanocytic skin cancer, and controlled breast or prostate cancer, can be included).
  • Subjects with severe chronic heart failure (New York Heart Association class III or IV).
  • Subjects with severe pulmonary disease (Global Obstructive Lung Disease stage III or IV).
  • Subjects with severe myopathy as defined clinically.
  • Subjects with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection.
  • Females who are pregnant, breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence*) throughout the study. - True abstinence: When this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [eg, calendar, ovulation, symptothermal, post-ovulation methods], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception).
  • Subjects with previous liver transplantation.
  • Subjects receiving anti-platelet or anti-coagulant therapy.
  • Participation in another clinical study within at least 30 days prior to screening.
  • Subjects with active drug addiction.
  • Subjects with a do-not-resuscitate order.
  • In the opinion of the investigator, the subject may have compliance problems with the protocol and the procedures of the protocol.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Douglas Simonetto, M.D.

Open for enrollment

Contact information:

Amy Olofson R.N.

(507) 284-2638

Olofson.Amy@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20492240

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