Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Albutein 20% · 1 trial · 1 indication
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 \[(participants with an event up to the analysis cut-off Day 361) / (number of participants in the ITT group)\].
| 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. |
| Name | Type | Description |
|---|---|---|
| Albutein 20% | DRUG | Injectable solution |
| SMT | OTHER | Participants received SMT according to institution standards for the management of decompensated cirrhosis. |
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 20% is a human albumin solution being studied for use in amyotrophic lateral sclerosis, decompensated cirrhosis with ascites, and Alzheimer's disease. It is developed by Grifols, S.A. and is currently in Phase 3 clinical development for these indications.
Albutein 20% is developed by Grifols, S.A., a biopharmaceutical company traded on the NASDAQ under the ticker GRFS. The company is conducting clinical trials to evaluate the drug's safety and efficacy in multiple disease areas.
Albutein 20% is in Phase 3 clinical development. One Phase 3 trial has been completed, and the drug remains investigational, meaning it has not yet been approved by regulatory authorities for commercial use.
Albutein 20% has been studied in three completed trials. NCT03451292 is a Phase 3 trial in decompensated cirrhosis and ascites with 410 participants. NCT00742417 and NCT02872142 are Phase 2 trials in Alzheimer's disease and amyotrophic lateral sclerosis, respectively.
Albutein 20% and Albutein 5% are both human albumin products from Grifols, but they differ in concentration. Clinical trials have used Albutein 5% for Alzheimer's disease and amyotrophic lateral sclerosis, while Albutein 20% is the formulation under investigation for cirrhosis.