Status:
COMPLETED
Effects of Long-Term Administration of Human Albumin in Participants With Decompensated Cirrhosis and Ascites
Lead Sponsor:
Grifols Therapeutics LLC
Collaborating Sponsors:
Instituto Grifols, S.A.
Conditions:
Decompensated Cirrhosis and Ascites
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- Male or female participants ≥18 years of age.
- Participants with diagnosis of liver cirrhosis (based on clinical, laboratory, endoscopic, and ultrasonographic features or on histology).
- Participants 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 participants with cirrhosis due to hepatitis B virus, decompensation must occur in the setting of continuous (no less than 3 months) appropriate antiviral therapy.
- In participants with cirrhosis due to hepatitis C virus, only decompensated participants who will not receive antiviral therapy during the study period will be included (Participants receiving antiviral therapy within 14 days prior to enrollment cannot be included in the study).
- In participants with cirrhosis due to autoimmune hepatitis, decompensation must occur in the setting of continuous immunosuppressive therapy.
- Participants 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 participant in accordance with local law and institutional policy.
- Chronic liver failure-consortium acute decompensation (CLIF-C AD) score \> 50 points at screening.
Exclusion
- Participants with ACLF at Screening
- Participants with type 1 hepatorenal syndrome (HRS) currently on treatment with vasoconstrictors or hemodialysis.
- Participants with transjugular intrahepatic portosystemic shunt (TIPS) or other surgical porto-caval shunts.
- Participants with refractory ascites as defined by the International Club of Ascites (ICA) criteria without any other event of acute decompensation.
- Participants receiving dual anti-platelet therapy or anti-coagulant therapy (exception: deep vein thrombosis (DVT) prophylaxis).
- Participants with ongoing endoscopic eradication of esophageal varices with ≤ 2 endoscopic sessions completed before screening.
- Participants with evidence of current locally advanced or metastatic malignancy.
- Participants with acute or chronic heart failure (New York Heart Association \[NYHA\]).
- Participants with severe (grade III or IV) pulmonary disease (Global Obstructive Lung Disease \[GOLD\]).
- Participants with nephropathy with renal failure with serum creatinine \>2 milligrams/deciliters (mg/dL) or systemic hypertension.
- Participants with severe psychiatric disorders.
- Participants 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 effective methods of contraception
- Participants with previous liver transplantation.
- Participants with known or suspected hypersensitivity to albumin.
- Participants participating in another clinical study within 3 months prior to screening.
- Participants with active drug addiction (exceptions: active alcoholism or marijuana).
- In the opinion of the investigator, the participants may have compliance problems with the protocol and the procedures of the protocol.
- Participants with ongoing or recent variceal bleeding (participants can be included 2 weeks after hemorrhagic episode).
- Participants with septic shock at screening.
- Participants with ongoing spontaneous bacterial peritonitis (SBP) infection (participants can be included upon resolution).
- Participants with current infection of coronavirus disease of 2019 (COVID19), those who are less than 14 days post recovery, or those who have clinical signs and symptoms consistent with COVID19 infection.
Key Trial Info
Start Date :
July 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 21 2024
Estimated Enrollment :
410 Patients enrolled
Trial Details
Trial ID
NCT03451292
Start Date
July 24 2018
End Date
May 21 2024
Last Update
June 6 2025
Active Locations (66)
Enter a location and click search to find clinical trials sorted by distance.
1
Southern California Research Center
Coronado, California, United States, 92118
2
University of Miami Hospital
Miami, Florida, United States, 33136
3
Rutgers-New Jersey Medical School
Newark, New Jersey, United States, 07103
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104