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

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ClinicalTrials.gov Identifier: NCT03451292
Recruitment Status : Recruiting
First Posted : March 1, 2018
Last Update Posted : March 13, 2019
Sponsor:
Collaborator:
Instituto Grifols, S.A.
Information provided by (Responsible Party):
Grifols Therapeutics LLC

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 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.

Condition or disease Intervention/treatment Phase
Decompensated Cirrhosis and Ascites Drug: Albutein 20% Injectable Solution Other: Standard medical treatment Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 410 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prevention of Mortality With Long-Term Administration of Human Albumin in Subjects With Decompensated Cirrhosis and Ascites
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

Arm Intervention/treatment
Experimental: SMT + Albutein 20% Drug: Albutein 20% Injectable Solution
Within 96 hours after discharge and following randomization, subjects will receive the first Albutein 20% infusion at the dose of 1.5 g/kg body weight (maximum 100 grams per subject). Thereafter, subjects will receive Albutein 20% infusions at the dose of 1.5 g/kg body weight (maximum 100 grams per subject) every 10 ± 2 days for the rest of the study (up to a maximum of 12 months). Subjects in this treatment group will also receive SMT.

Other: Standard medical treatment
Subjects will receive SMT according to published guidelines for the management of decompensated cirrhosis.

Active Comparator: SMT Other: Standard medical treatment
Subjects will receive SMT according to published guidelines for the management of decompensated cirrhosis.




Primary Outcome Measures :
  1. Time to liver transplantation or death (whichever comes first) through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Time to liver transplantation or death (whichever comes first) through 3 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 3 months ]
  2. Time to liver transplantation or death (whichever comes first) through 6 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 6 months ]
  3. Time to death through 3 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 3 months ]
  4. Time to death through 6 months after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 6 months ]
  5. Time to death through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 12 months ]
  6. Total number of paracenteses through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 12 months ]
  7. Total number of incidences of refractory ascites according to the International Club of Ascites (ICA) through 1 year after randomization in subjects receiving SMT + Albutein 20% administration versus subjects receiving SMT alone [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with diagnosis of liver cirrhosis and uncomplicated ascites according to the ICA criteria
  • 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 ACLF at admission or during hospitalization but without ACLF at discharge
  • Subjects with ongoing diuretic treatment with an anti-mineralocorticoid drug at a dose of ≥100 mg/day and furosemide ≥40 mg/day independent of response to treatment
  • In subjects with cirrhosis due to hepatitis B virus, decompensation must occur in the setting of continuous (not <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
  • In subjects with cirrhosis due to autoimmune hepatitis, decompensation must occur in the setting of continuous immunosuppressive therapy

Exclusion Criteria:

  • Subjects with ongoing ACLF at discharge
  • Subjects with ongoing or recent (within the last 30 days) hepatorenal syndrome (HRS), infection, or bleeding complications
  • Subjects with transjugular intrahepatic portosystemic shunt (TIPS) or other surgical porto-caval shunts
  • Subjects with an established diagnosis of refractory ascites as defined by ICA criteria
  • Subjects requiring ≥2 paracenteses during the previous 30 days
  • Subjects receiving anti-platelet therapy or anti-coagulant therapy during the previous 30 days
  • Subjects with ongoing endoscopic eradication of esophageal varices at discharge
  • Subjects with hepatic encephalopathy grade III or IV
  • Subjects with evidence of current locally advanced or metastatic malignancy. Subjects with hepatocellular carcinoma within the Milan criteria, non-melanocytic skin cancer, or controlled breast or prostate cancer can be included
  • Subjects with chronic heart failure
  • Subjects with severe (grade III or IV) pulmonary disease
  • Subjects with serum creatinine >2.0 x upper limit of normal
  • Subjects with organic nephropathy as defined by ICA criteria
  • Subjects with sever psychiatric disorders
  • 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 throughout the study
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03451292


Contacts
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Contact: Mireia Torres +34 93 5712273 mireia.torres@grifols.com
Contact: Ed Corsi +1 9193166222 Ed.Corsi@grifols.com

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Sponsors and Collaborators
Grifols Therapeutics LLC
Instituto Grifols, S.A.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Grifols Therapeutics LLC
ClinicalTrials.gov Identifier: NCT03451292     History of Changes
Other Study ID Numbers: IG1601
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Cirrhosis
Fibrosis
Ascites
Pathologic Processes
Liver Diseases
Digestive System Diseases