Effects of Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites

  • STATUS
    Recruiting
  • End date
    Mar 25, 2023
  • participants needed
    410
  • sponsor
    Grifols Therapeutics LLC
Updated on 25 July 2021

Summary

This is a phase 3, multicenter, randomized, controlled, parallel-group, and open-label clinical study to evaluate the efficacy of standard medical treatment (SMT) + Albutein 20% administration versus SMT alone in subjects with decompensated cirrhosis and ascites. The study population will consist of subjects being discharged after hospitalization for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without acute-on-chronic liver failure (ACLF) at admission or during hospitalization but without ACLF at discharge.

Details
Condition Decompensated Cirrhosis and Ascites
Treatment Standard Medical Treatment, Albutein 20% Injectable Solution
Clinical Study IdentifierNCT03451292
SponsorGrifols Therapeutics LLC
Last Modified on25 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female subject 18 years of age
Subjects with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology)
Subjects who have been hospitalized for acute decompensation of liver cirrhosis with ascites (or with prior history of ascites requiring diuretic therapy) with or without ACLF at admission or during hospitalization but without ACLF at Screening
In subjects with cirrhosis due to hepatitis B virus, decompensation must occur in the setting of continuous (no less than 3 months) appropriate antiviral therapy
In subjects with cirrhosis due to hepatitis C virus, only decompensated patients who will not receive antiviral therapy during the study period will be included (Subjects receiving antiviral therapy within 14 days prior to enrollment cannot be included in the study)
In subjects with cirrhosis due to autoimmune hepatitis, decompensation must occur in the setting of continuous immunosuppressive therapy
Subjects must be 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
CLIF-C AD score > 50 points at screening

Exclusion Criteria

Subjects with ACLF at Screening
Subjects with type 1 HRS currently on treatment with vasoconstrictors or hemodialysis
Subjects with TIPS or other surgical porto-caval shunts
Subjects with refractory ascites as defined by ICA criteria without any other event of acute decompensation
Subjects receiving dual anti-platelet therapy or anti-coagulant therapy (exception: DVT prophylaxis)
Subjects with ongoing endoscopic eradication of esophageal varices with 2 endoscopic sessions completed before screening
Subjects with evidence of current locally advanced or metastatic malignancy
Subjects with acute or chronic heart failure (New York Heart Association [NYHA])
Subjects with severe (grade III or IV) pulmonary disease (Global Obstructive Lung Disease [GOLD])
Subjects with nephropathy with renal failure with serum creatinine >2 mg/dL or systemic hypertension
Subjects with severe psychiatric disorders
Females who are pregnant, breastfeeding, or if of childbearing potential, unwilling to practice effective methods of contraception
Subjects with a known infection with human immunodeficiency virus (HIV) or have clinical signs and symptoms consistent with current HIV infection
Subjects with previous liver transplantation
Subjects with known or suspected hypersensitivity to albumin
Subjects participating in another clinical study within 3 months prior to screening
Subjects with active drug addiction (exceptions: active alcoholism or marijuana)
In the opinion of the investigator, the subject may have compliance problems with the protocol and the procedures of the protocol
Subjects with ongoing or recent variceal bleeding (subjects can be included 2 weeks after hemorrhagic episode)
Subjects with septic shock at screening
Subjects with ongoing SBP infection (subjects can be included upon resolution)
Subjects with current infection of COVID19, those who are less than 14 days post recovery, or those who have clinical signs and symptoms consistent with COVID19 infection
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