EUCTR2017-002677-19-ITActive, not recruitingPhase 1
Pathogenesis of Acute on Chronic Liver Failure (ACLF) and Mechanisms of Action of Plasma Exchange with Human Serum Albumin 5% (PE-A 5%) in Decompensated Cirrhotic Subjects with Systemic Inflammation and ACLF - ALADDI
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- INSTITUTO GRIFOLS, S.A.
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
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