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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02461992 | Study of PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Male Chinese Subjects With Hemophilia A | PHASE1 | COMPLETED | 13 | — | — | Jul 1, 2015 | Aug 1, 2015 | Sep 7, 2016 | 2 | China |
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Volume of distribution is the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the volume of distribution at steady-state.
Terminal phase rate constant is the absolute value of the slope of a linear regression during the terminal phase of the natural--logarithm transformed concentration--time profile.
Terminal half-life is the time measured for the plasma concentration to decrease by one half.
MRT = AUMCinf / AUCinf, where AUMCinf is the area under the first moment curve from zero time to infinity calculated as AUMCinf = AUMCt + ((t x Ct) / kel) + (Ct / kel\^2). AUMCt is the area under the first moment curve from zero time to time t calculated using the trapezoidal method.
Incremental recovery is the increase in circulating FVIII activity for every IU of Xyntha administered per kilogram of body weight.
| Arm | Type | Description |
|---|---|---|
| Intravenous infusion of Xyntha | EXPERIMENTAL | observation arm |
| Name | Type | Description |
|---|---|---|
| Intravenous infusions of Xyntha | DRUG | A single dose 50IU/kg dose of Xyntha administered by intravenous infusion within 10 minutes on Day 1 |
Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study: 1. Male Chinese subjects 6 years or older (weight \>20 kg) with severe hemophilia A (factor VIII activity \<1%) previously treated with \> 150 exposure days to any FVIII-conta...