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Trial record 1 of 1 for:    preciosa albumin | cirrhosis
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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 : April 24, 2023
Sponsor:
Collaborator:
Instituto Grifols, S.A.
Information provided by (Responsible Party):
Grifols Therapeutics LLC

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 410 participants
Allocation: 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 : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Standard Medical Treatment + Albutein 20%
Standard Medical Treatment plus Albutein 20% administrations
 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: Standard Medical Treatment
The sites will follow the Standard Medical Treatment as per their Standard of Care.
 Other: Standard medical treatment
Subjects will receive SMT according to published guidelines for the management of decompensated cirrhosis.


Outcome Measures
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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 ]

Eligibility Criteria
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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:

  • 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.
  • 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 effective methods of contraception
  • 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.
Contacts and Locations
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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 5710500 approach_preciosa@grifols.com

Locations
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Sponsors and Collaborators
Grifols Therapeutics LLC
Instituto Grifols, S.A.
More Information
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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    
Other Study ID Numbers: IG1601
First Posted: March 1, 2018    Key Record Dates
Last Update Posted: April 24, 2023
Last Verified: April 2023

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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