Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Xyntha · 1 trial · 1 indication
The Investigator Hemostatic Efficacy Assessment was based on a 4-point rating scale (Excellent = 1: definite pain relief or improvement in signs of bleeding, with no additional infusion, Good = 2: definite pain relief or improvement in signs of bleeding, Moderate = 3: probable or slight improvement, No Response = 4: no improvement at all between infusions).
The Investigator Hemostatic Efficacy Assessment was based on a 4-point rating scale (Excellent = 1: definite pain relief or improvement in signs of bleeding, with no additional infusion, Good = 2: definite pain relief or improvement in signs of bleeding, Moderate = 3: probable or slight improvement, No Response = 4: no improvement at all between infusions).
Incidence of FVIII inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory. Incidence was stratified by participant exposure history: Minimally Treated Patients (MTPs): those who had received at least 1 prior FVIII infusion, and \<= 100 documented Exposure Days (EDs), while Previously Treated Patients (PTPs): those who had received \>100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.
| Arm | Type | Description |
|---|---|---|
| Xyntha | EXPERIMENTAL | This trial was an open-label and included assessments of safety, clinical efficacy, and Factor VIII (FVIII) recovery in Chinese subjects with hemophilia A. Subjects received on-demand treatments with Xyntha over a 6-month (calendar day) period. |
| Name | Type | Description |
|---|---|---|
| Xyntha | BIOLOGICAL | Xyntha for on-demand treatment of bleeding episodes were according to investigator prescription during the 6 months observation period. The recovery assessed by determining the Factor VIII (FVIII) concentration (FVIII:C) levels in individual subjects at the initial and final visits. The dose of Xyntha for recovery assessments is: single 50 IU/kg (±5 IU/kg) IV bolus infusion. All Xyntha administrations occurred in the clinic (hospital). |
Inclusion Criteria: * Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia A (FVIII activity: more than 5%, 1-5%, or less than 1%, respectively) * Subjects with previous exposure to FVIII replacement therapy * If human immunodeficiency virus (HIV) positive, documented...
Xyntha is used for the treatment of Hemophilia A. It is a monoclonal antibody being developed by Pfizer, Inc. for this hematologic condition. The drug is currently in Phase 3 clinical development, and it is intended for patients with Hemophilia A, a bleeding disorder.
Xyntha is developed by Pfizer, Inc., a pharmaceutical company listed on the stock exchange under the ticker symbol PFE. Pfizer is conducting clinical trials to evaluate the safety and efficacy of Xyntha for the treatment of Hemophilia A.
Xyntha is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial for Xyntha has been completed, and it is being studied for the treatment of Hemophilia A.
Xyntha has been studied in a Phase 3 clinical trial with the identifier NCT00868530. This trial, titled 'Study Evaluating On-Demand Treatment Of Xyntha In Chinese Subjects', was completed and enrolled 53 participants with Hemophilia A. The trial was conducted in China and included patients aged 6 years and older.
Xyntha is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for the treatment of Hemophilia A. The Phase 3 trial has been completed, but regulatory approval has not been granted. Further development and regulatory review are required before it can be marketed.