Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Prolastin-C
Prolastin-C,kg · 1 trial · 2 indications
Number of subjects experiencing at least one TEAE. TEAEs were defined as any adverse event (AE) during the study that began on or after the date of first dose of investigational product (i.e., Prolastin-C).
Number of subjects with at least one TEAE that was determined by the Investigator to be either "possibly related" or "related" to the investigational product (i.e., Prolastin-C).
Number of subjects who experienced at least one treatment-emergent SAE.
Number of subjects who were withdrawn from the study due to at least one AE.
Number of subjects with at least one treatment-emergent pulmonary exacerbation
Number of subjects who experienced at least one severe TEAE or pulmonary exacerbation.
Total number of TEAEs reported.
Total number of drug-related TEAEs reported
Total number of treatment-emergent pulmonary exacerbations.
| Arm | Type | Description |
|---|---|---|
| Prolastin-C, 60 mg/kg | ACTIVE_COMPARATOR | 60 mg/kg weekly infusion of Prolastin-C for 8 weeks. Subjects were infused with 60 mg/kg Prolastin-C by means of one of two possible treatment sequences: 1) 60 mg/kg weekly infusion of Prolastin-C for 8 weeks followed by 120 mg/kg Prolastin-C for 8 weeks, or 2) 120 mg/kg Prolastin-C for 8 weeks followed by 60 mg/kg weekly infusion of Prolastin-C for 8 weeks (total of 16 weeks). |
| Prolastin-C, 120 mg/kg | EXPERIMENTAL | 120 mg/kg weekly infusion of Prolastin-C for 8 weeks. Subjects were infused with 120 mg/kg Prolastin-C by means of one of two possible treatment sequences: 1) 60 mg/kg weekly infusion of Prolastin-C for 8 weeks followed by 120 mg/kg Prolastin-C for 8 weeks, or 2) 120 mg/kg Prolastin-C for 8 weeks followed by 60 mg/kg weekly infusion of Prolastin-C for 8 weeks (total of 16 weeks). |
| Name | Type | Description |
|---|---|---|
| Prolastin-C, 60 mg/kg | BIOLOGICAL | 60 mg/kg weekly infusion of Prolastin-C for 8 weeks |
| Prolastin-C, 120 mg/kg | BIOLOGICAL | 120 mg/kg weekly infusion of Prolastin-C for 8 weeks |
Inclusion Criteria: * Be between 18 and 70 years of age * Have a documented diagnosis of congenital AATD * Have a post-bronchodilator Forced Expired Volume in 1 second (FEV1) of ≥30% and \<80% and FEV1/forced vital capacity (FVC) \<70% * If receiving alpha-1 PI augmentation therapy, be willing to d...
Prolastin-C is studied for emphysema associated with alpha-1 antitrypsin deficiency (AATD), a rare inherited condition affecting the lungs. It is a biologic developed by Grifols, S.A. The clinical program has focused on safety and pharmacokinetics in adults with AATD-related emphysema rather than on a broad set of lung diseases.
Prolastin-C is developed by Grifols, S.A., which trades under the ticker GRFS. Grifols is the company named as the developer of this alpha-1 proteinase inhibitor biologic, and it is being studied in the rare disease therapeutic area for emphysema linked to alpha-1 antitrypsin deficiency.
Prolastin-C is in Phase 2 clinical development. Its recorded trial program consists of one completed Phase 2 study, which enrolled 30 participants. The drug is investigational in this emphysema and alpha-1 antitrypsin deficiency setting, and the available development record does not extend beyond that Phase 2 stage.
Prolastin-C has been evaluated in trial NCT01213043, titled Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency. The Phase 2 study enrolled 30 adults aged 18 years and older in the United States, included both sexes, and is completed. It was randomized, double-blind, and active-controlled.
Trial NCT01213043 evaluated safety and pharmacokinetics of the alpha-1 proteinase inhibitor in subjects with alpha-1 antitrypsin deficiency. The completed Phase 2 study enrolled 30 adults in the United States and used a randomized, double-blind, active-controlled design, comparing Prolastin-C against an active comparator rather than a placebo.