Table 3.
Analysis of C1-INH antigen levels after IV and SC administration of C1-INH concentrate (pharmacokinetic per-protocol set)*
| Variable | Mean (SD) | p value | |
|---|---|---|---|
| IV (n = 16)† | SC (n = 16)† | ||
| AUC (hr × mg/mL) | 4.7 (1.07) | 2.7 (1.84) | 0.0008 |
| AUCst‡ (hr × mg/mL) | 0.6 (0.14) | 0.3 (0.24) | 0.0030 |
| Tmax (hr)§ | 0.4 (0-36) | 48.1 (1-456) | 0.0052 |
| Cmax (mg/mL)|| | 0.09 (0.044) | 0.03 (0.021) | <0.0001 |
| t1/2 (hr) | 53.3 (28.19) | 94.4 (71.61) | 0.0643 |
| MRT (hr) | 54.9 (26.55) | 106.2 (58.99) | 0.0041 |
| CL [U/(hr × mg/mL)] | 206.8 (64.91) | 556.2 (777.85) | 0.0424 |
| VZ [U/(mg/mL)] | 14,842.7 (7,438.10) | 49,503.6 (51,319.02) | 0.0053 |
*
p values are shown for the factor of “treatment” in an analysis of variance conducted for each pharmacokinetic variable including factors of “treatment,” “period,” and “treatment × period.” The factors of “period” and “treatment × period” had no effect on any of the pharmacokinetic variables.
†
Seven subjects with HAE Type II were excluded from the C1-INH antigen analyses.
‡
Standardized to 15 U/kg body weight.
*
Median (range).
||
Mean values were not rounded to one decimal place to avoid values of 0.0; decimal places of the corresponding SD were rounded accordingly.