Biological mechanisms of Acute on Chronic Liver Failure (ACLF) and Mechanisms of Action of Plasma Exchange with Human Serum Albumin 5% in Subjects with cirrhosis with systemic inflammation and ACLF

Phase 1

Conditions: Group 1 and 2:Subjects with cirrhosis with ACLF-1b, ACLF-2, or ACLF-3a detected either at admission or during hospitalization Group 3: Subject with cirrhosis hospitalized for Acute decompensation of cirrhosis (ascites, hepatic encephalopathy [HE], gastrointestinal hemorrhage, and/or bacterial infections)
MedDRA version: 20.1Level: LLTClassification code 10064704Term: Decompensated cirrhosisSystem Organ Class: 100000004871
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2017-002677-19-IT

Lead Sponsor: INSTITUTO GRIFOLS, S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

Inclusion Criteria

Subjects enrolled in Group 1 and 2 must meet all the following inclusion criteria to be eligible for participation in this study:
1. Be enrolled at European study centers of the APACHE study which are also participating in the ALADDIN study.
2. Have signed the informed consent form (ICF) to participate in the ALADDIN study.

Subjects enrolled in Group 3 must meet all the following inclusion criteria to be eligible for participation in this study:
1. Male or female cirrhotic subject between 18 and 79 years of age.
2. Hospitalized for AD of cirrhosis (ascites, HE, gastrointestinal hemorrhage and/or
bacterial infections). Bacterial infections are considered an AD of cirrhosis only in
subjects with prior history of decompensated cirrhosis.
3. 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

Subjects in Group 3 meeting any of the following exclusion criteria are NOT eligible for participation in the study:
1. Subjects with ACLF (any grade).
2. Subjects with septic shock lasting >1 hour that does not respond to fluid resuscitation intravenous (IV) therapy or pharmacologic-pressors.
3. Subjects with active bacterial or fungal infection with hemodynamic instability.
4. Subjects with active or recent bleeding (unless controlled for >48 hours).
5. Subjects with chronic renal failure and currently receiving hemodialysis.
6. 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).
7. Subjects with severe chronic heart failure (New York Heart Association [NYHA] class III or IV).
8. Subjects with severe pulmonary disease (Global Obstructive Lung Disease [GOLD] stage III or IV).
9. Subjects with severe critical illness myopathy as defined clinically.
10. Subjects with a known infection with human immunodeficiency virus (HIV) or clinical signs and symptoms consistent with current HIV infection.
11. Females who are pregnant.
12. Subjects with previous liver transplantation.
13. Subjects receiving anti-platelet or anti-coagulant therapy.
14. Participation in another clinical study within at least 30 days prior to screening.
15. Subjects with active drug addiction.
16. Subjects with a do-not-resuscitate order.
17. Subjects who, in the opinion of the investigator, may have compliance problems with the protocol and the procedures of the protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To investigate the pathogenesis of systemic inflammation, organ failure (OF), and ACLF in cirrhosis<br>- To explore mechanisms of action of PE-A 5% in subjects with ACLF;Secondary Objective: Not applicable;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

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