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Alpha1-Proteinase Inhibitor · 3 trials · 2 indications
An adverse event is any untoward medical occurrence in a subject or clinical investigation subject administered with a pharmaceutical product. The adverse event does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of an investigational product, whether or not considered related to the medicinal product.
| Arm | Type | Description |
|---|---|---|
| Alpha-1 Proteinase Inhibitor (Human), modified process | EXPERIMENTAL | Study the safety and tolerability of weekly infusions of Alpha-1 Proteinase Inhibitor (Human), modified process (Alpha-1 MP, 60 mg/kg) over 20 weeks of therapy in adult Alpha-1 antitrypsin deficient subjects. |
| Group 1 | EXPERIMENTAL | Prolastin |
| Group 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| alpha-1 proteinase inhibitor (human) | DRUG | 60 mg/kg weekly for 20 weeks |
| Alpha1-Proteinase Inhibitor (Human) | DRUG | Weekly infusion of 60 mg/kg body weight for 2 years |
| Albumin (Human) 20%, United States Pharmacopeia (USP) | DRUG | Weekly infusion for 2 years. Albumin (Human) 20% will be diluted with 5% glucose to a final concentration of 2.0%. |
Inclusion Criteria: * Documented diagnosis of congenital Alpha1-antitrypsin deficiency * Documented forced expiratory volume in 1 second (FEV1 ) between 20% - 80% of predicted value within last 6 months. * Signed written informed consent prior to initiation of any study related procedures. Exclusi...
Alpha1-Proteinase Inhibitor is being studied for the treatment of Cystic Fibrosis and Alpha 1-Antitrypsin Deficiency. It is an investigational therapy in clinical development, and it is not yet approved for these indications.
Alpha1-Proteinase Inhibitor is being developed by Grifols, S.A., a biopharmaceutical company. Grifols is publicly traded under the ticker symbol GRFS.
Alpha1-Proteinase Inhibitor is in Phase 3 clinical development. It has completed two trials, including a Phase 3 study, and is still being evaluated for safety and efficacy in patients with Alpha 1-Antitrypsin Deficiency.
Alpha1-Proteinase Inhibitor has been studied in three completed clinical trials. These include NCT00263887, a Phase 2 study in Alpha 1-Antitrypsin Deficiency; NCT00301366, a Phase 3 safety and tolerability study in the same condition; and NCT00486837, a Phase 2 study in Cystic Fibrosis.
Alpha1-Proteinase Inhibitor is also known as Alpha-1-Antitrypsin. Clinical trials for this drug, such as NCT00263887 and NCT00301366, refer to it as Alpha-1-Antitrypsin (AAT) therapy.