Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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Number of subjects who were withdrawn from the study due to at least one AE.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 used for emphysema in patients with alpha-1 antitrypsin deficiency (AATD). It is an investigational monoclonal antibody being developed by Grifols, S.A. for this rare disease indication. The drug is currently in Phase 2 clinical development.
Prolastin-C is a monoclonal antibody. Its specific molecular target has not been disclosed in the available information. The drug is being studied for its potential to treat emphysema associated with alpha-1 antitrypsin deficiency.
Prolastin-C is being developed by Grifols, S.A., a biopharmaceutical company. Grifols is listed on the stock exchange under the ticker symbol GRFS. The company is conducting clinical trials to evaluate the drug for the treatment of emphysema.
Prolastin-C is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is not currently in active clinical trials.
Prolastin-C has one completed clinical trial, identified as NCT01213043. This Phase 2 study evaluated the safety and pharmacokinetics of the drug in subjects with alpha-1 antitrypsin deficiency and emphysema. The trial enrolled 30 participants in the United States.
Prolastin-C is a form of alpha-1 proteinase inhibitor, as indicated by the clinical trial title. The study NCT01213043 investigated alpha-1 proteinase inhibitor in subjects with alpha-1 antitrypsin deficiency. Prolastin-C is the brand name for this product.