Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01213043 | Safety and Pharmacokinetics of Alpha-1 Proteinase Inhibitor in Subjects With Alpha1-Antitrypsin Deficiency | PHASE2 | COMPLETED | 30 | — | — | Nov 1, 2010 | Jan 1, 2012 | May 20, 2013 | 5 | United States |
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Number of subjects who were withdrawn from the study due to at least one AE.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...