Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Albutein 5% · 2 trials · 2 indications
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 |
|---|---|---|
| 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 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: * Signed informed consent * Subjects over 18 years of age and less than 70 years old * Subjects with a possible, probable-lab supported, probable, or definite diagnosis of Amyotrophic Lateral Sclerosis (ALS), according to the revised El Escorial criteria * Subjects having experi...
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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.