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Also known as Albumin, Albutein® 5%, Human Albumin Grifols 5%
Albumin 5% · 2 trials · 2 indications
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) includes 12 questions classified into 3 subdomains: bulbar function (3 questions), fine and gross motor skills (6 questions), and respiratory function (3 questions) to assess the level self sufficiency. Each task was graded according to a 5-point scale from 0 (incapable) to 4 (normal ability) with a total score from 0 (worst) to 48 (best).
ADAS-Cog total score as a change from baseline to 14 months The ADAS-Cog Scale is a questionnaire that assesses cognitive performance in 12 different domains. The domains are: word recall, commands, constructional praxis, delayed word-recall task, naming objects/figures, ideational praxis, orientation, word recognition, remembering test instructions, comprehension, word finding difficulty, and spoken language ability. The total score ranges from 0-80 where a higher score indicates more cognitive impairment.
ADCS-ADL total score as a change from baseline to 14 months The ADCS-ADL comprises 23 questions covering a wide array of activities of daily living. Many of the activities begin with an assessment of whether that activity is relevant and then, if yes, follow with an assessment of the difficulty. The total score over all activities ranges from 0-78 where a higher score indicates more autonomy (better outcome).
| Arm | Type | Description |
|---|---|---|
| Albumin | EXPERIMENTAL | Plasma exchange with Albumin |
| High Albumin + Immunoglobulin | EXPERIMENTAL | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with high dose of albumin 20% or immunoglobulin 5% (maintenance treatment period) |
| Low Albumin + Immunoglobulin | EXPERIMENTAL | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% or immunoglobulin 5% (maintenance treatment period) |
| Low Albumin | EXPERIMENTAL | Therapeutic plasma exchange with albumin 5% (intensive treatment period) + Low volume plasma exchange with low dose of albumin 20% (maintenance treatment period) |
| Control (sham) group | NO_INTERVENTION | Simulated plasma exchange procedure |
| Name | Type | Description |
|---|---|---|
| Albumin | BIOLOGICAL | 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution: * three weeks of intensive treatment with two plasma exchanges per week * twenty-one weeks of maintenance treatment with one weekly plasma exchange |
| Albumin 5% | BIOLOGICAL | Therapeutic plasma exchange with human albumin 5% |
| Albumin 20% | BIOLOGICAL | Low volume plasma exchange with human albumin 5% |
| Immunoglobulin | BIOLOGICAL | Intravenous human immunoglobulin 5% |
Inclusion Criteria: * Signed written-informed consent. * Subjects over 18 years of age, and less than 70 years old. * Subjects with a definite, possible, or probable diagnosis of ALS, according to the revised El Escorial criteria. * Subjects having experienced their first ALS symptoms within 18 mon...
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Albumin 5% has been studied in clinical trials for Alzheimer's disease and amyotrophic lateral sclerosis, also known as ALS. It is a plasma-derived human albumin product developed by Grifols, S.A. under the ticker GRFS. Both programs are Phase 2 and the trials have been completed.
Albumin 5% is made by Grifols, S.A., which trades under the ticker GRFS. Grifols is the developer associated with the clinical programs studying this human albumin product in Alzheimer's disease and amyotrophic lateral sclerosis.
Albumin 5% is in Phase 2 development. It is investigational and is not approved for Alzheimer's disease or amyotrophic lateral sclerosis. Two Phase 2 trials have been completed, and no trials are currently active.
Albumin 5% has been studied in two completed Phase 2 trials. NCT01561053 evaluated albumin and immunoglobulin in Alzheimer's disease across the United States and Spain with 347 participants. NCT02479802 evaluated plasma exchange with albumin in amyotrophic lateral sclerosis in Spain with 13 participants.
Yes. Albumin 5% is also known as Albumin, Albumin (Human) 20% United States Pharmacopeia, Albumin 20% United States Pharmacopeia, Albumin (Human) 25% United States Pharmacopeia, and Albumin 25% United States Pharmacopeia. These names refer to the same human albumin product.
The Albumin 5% clinical program enrolled 347 participants in total. The Alzheimer's disease trial NCT01561053 accounted for 347 participants, while the amyotrophic lateral sclerosis trial NCT02479802 enrolled 13 participants. Both were randomized, double-blind Phase 2 studies.