Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
infusions of Xyntha · 1 trial · 1 indication
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...
Xyntha is used for the treatment of Hemophilia A. It is a recombinant factor VIII product administered by infusion. The drug is being studied in male Chinese subjects with Hemophilia A, with a completed Phase 1 clinical trial.
Xyntha is developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. Pfizer is conducting clinical research on Xyntha for Hemophilia A.
Xyntha is in Phase 1 clinical development. A Phase 1 study of Xyntha has been completed. The drug is investigational and not yet approved for general use.
Xyntha has one completed clinical trial, identified as NCT02461992. This Phase 1 study, titled "Study of PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Male Chinese Subjects With Hemophilia A," enrolled 13 participants in China.
Yes, Xyntha is also known as PF-05208756 and moroctocog alfa (AF-CC). These names refer to the same drug product. The clinical trial NCT02461992 uses these names interchangeably to describe the treatment.