Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Intravenous infusions of Xyntha
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...
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|---|---|---|---|---|
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 15 | PHASE3 | Concizumab, Mim8, Denecimig, NNC0442-0344 A, turoctocog alfa pegol |
| Sanofi SA Sponsored ADR | SNY | 5 | PHASE3 | Fitusiran, efanesoctocog alfa |
| Pfizer Inc. | PFE | 8 | PHASE3 | Fidanacogene elaparvovec, Marstacimab |
| BioMarin Pharmaceutical Inc. | BMRN | 2 | PHASE3 | Valoctocogene roxaparvovec |
| Hoffmann-La Roche | RHHBY | 8 | PHASE3 | Emicizumab, NXT007, SPK-8011QQ, SPK-8011, SPK-8016 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | REGV131, LNP1265 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE1 | AskBio009 |
| Bayer | BAYRY | 6 | - | Damoctocog-alfa-pegol |
Infusions of Xyntha are used to treat Hemophilia A, a bleeding disorder. The drug is given intravenously and was studied in male Chinese subjects with Hemophilia A, including children as young as 6 years old. It is being developed by Pfizer, Inc. under the ticker PFE.
Infusions of Xyntha are made by Pfizer, Inc., which trades under the ticker PFE. Pfizer is the developer of this therapy for Hemophilia A.
Infusions of Xyntha are in Phase 1 clinical development. The only listed trial for this drug is a completed Phase 1 study, so it is investigational and not yet approved.
One clinical trial has been conducted with infusions of Xyntha: NCT02461992, titled "Study of PF-05208756, Moroctocog Alfa (AF-CC), Xyntha For Male Chinese Subjects With Hemophilia A." This Phase 1 trial was completed and enrolled 13 male participants in China.
Yes, infusions of Xyntha is also known as Intravenous infusions of Xyntha. Both names refer to the same Pfizer product being studied for Hemophilia A.