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Also known as Albutein 20%, Albutein 5% solution for perfusion, Albumin, Human Albumin 5%
Albutein 5% · 3 trials · 3 indications
Time to one-year transplant-free survival was calculated as earlier of \[(date of liver transplantation or date of death) - randomization date + 1\] for participants who died or had liver transplant within the analysis period of 361 days. Participants who neither died nor had liver transplant within analysis period had their time to event censored at earlier of date of last contact or cut-off date. Participants who terminated early for reasons other than death were followed up at months 3, 6, and 12 to collect information on liver transplantation and death, these events if reported by cut-off Day 361, were considered for the endpoint. The percentage of participants with events are presented. The percentage of participants was calculated as \[(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)\].
The ALSFRS-R includes 12 questions to assess the self-sufficiency of participants in 3 sub-domains: bulbar function (questions 1-3), fine and gross motor function (questions 4-9), and respiratory function (question 10-12). Aspects of nourishment, personal care, personal autonomy, and communication were also evaluated. Each task was graded on a five-point scale from 0 (incapable) to 4 (normal ability), with total score range from 0 (worst) to 48 (best). A positive change from Baseline indicates improvement.
The FVC measured the volume of air that can forcibly be exhaled through a spirometer after a full inspiration. It was expressed in a percentage of actual FVC over the expected FVC result in the general population, calculated as: Percent predicted FVC (in %) = \[(observed FVC in liters)/(predicted FVC in liters)\]\*100.
Change in levels of Aβ1-42 in CSF in the period between baseline lumbar puncture (before the start of treatment) and lumbar puncture immediately after the end of the last plasma exchange (whenever this may be). Separate assays of Aβ1-42 were performed with Innotest and The Genetics Company commercial kits.
| Arm | Type | Description |
|---|---|---|
| SMT + Albutein 20% | EXPERIMENTAL | Participants received Albutein 20%, at a dose of 1.5 grams/kilograms (g/kg), based on their body weight (maximum 100 grams per participant), as an intravenous (IV) infusion on Day 1, followed by the same dose of Albutein 20% every 10±2 days along with standard medical treatment (SMT) administered as per institution standards for the management of decompensated cirrhosis up to 12 months. |
| SMT | ACTIVE_COMPARATOR | Participants received SMT up to 12 months as per institution standards for the management of decompensated cirrhosis. |
| Albutein 5% | EXPERIMENTAL | Plasma exchanges (PEs) with albutein 5% as a replacement solution during an intensive treatment phase of two PEs per week over 3 weeks followed by maintenance treatment phase of weekly PE for 21 weeks. The dose of albutein 5% for replacement following plasma removal was calculated based on gender, weight, and the hematocrit of the participant. |
| Control | SHAM_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Albutein 20% | DRUG | Injectable solution |
| SMT | OTHER | Participants received SMT according to institution standards for the management of decompensated cirrhosis. |
| Albutein 5% | BIOLOGICAL | Albutein is manufactured from human plasma. The dose of Albutein 5% for replacement following plasma removal will be calculated based on gender, weight, and the hematocrit of the participant. |
| Plasma Exchange | PROCEDURE | Plasma Exchange will be performed using albutein 5% as the replacement solution. |
| Control | OTHER | Control group followed the same schedule; however, they did not undergo plasma replacement (it was subjected to simulated plasma replacements) |
Inclusion Criteria: * 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...
Albutein 5% is a human albumin product developed by Grifols, S.A. (ticker GRFS). It is being studied in clinical trials for Alzheimer's disease, amyotrophic lateral sclerosis, and decompensated cirrhosis with ascites. The product is also known as Albutein 20%.
Albutein 5% is used in a Phase 2 clinical trial to evaluate plasma exchange with 5% albumin for beta-amyloid peptide clearance in cerebrospinal fluid in participants with Alzheimer's disease. The trial, NCT00742417, enrolled 42 participants in the United States and Spain.
Albutein 5% is made by Grifols, S.A., a company traded under the ticker GRFS. Grifols is developing the product for multiple indications, including Alzheimer's disease, amyotrophic lateral sclerosis, and decompensated cirrhosis with ascites.
Albutein 5% is in Phase 2 clinical development. It has been tested in completed Phase 2 trials for Alzheimer's disease and amyotrophic lateral sclerosis, and in a completed Phase 3 trial for decompensated cirrhosis and ascites. It is investigational and has not been approved by the FDA for these indications.
Albutein 5% has been studied in three completed clinical trials: NCT03451292, a Phase 3 trial in decompensated cirrhosis and ascites with 410 participants; NCT02872142, a Phase 2 trial in amyotrophic lateral sclerosis with 12 participants; and NCT00742417, a Phase 2 trial in Alzheimer's disease with 42 participants.
Albutein 5% is also known as Albutein 20%. Both names refer to the same human albumin product developed by Grifols, S.A. (ticker GRFS). The percentage likely denotes different concentrations of the albumin solution.