Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAX855 · 1 trial · 1 indication
Inhibitory antibodies to Factor VIII were measured by the Nijmegen modification of the Bethesda assay. Inhibitors had to be confirmed by 2 separate assessments within a 2 to 4 week period from the central laboratory.
The ABR was assessed based upon each individual bleeding episode. A bleeding episode was defined as subjective (pain consistent with a joint bleed) or objective evidence of bleeding which may or may not require treatment with FVIII. The ABR of spontaneous bleeds was reported separately for twice weekly, PK-t R, each of the every 5 days and every 7 days treatment regimens at the time of bleed.
| Arm | Type | Description |
|---|---|---|
| Fixed BAX855 prophylaxis | EXPERIMENTAL | 45-80 IU/kg twice weekly to once per week. |
| Pharmacokinetic (PK)-tailored BAX 855 prophylaxis | EXPERIMENTAL | PK-tailored prophylactic BAX855 regimen based on participant's individual PK profile to maintain a Factor VIII (FVIII) trough level |
| Name | Type | Description |
|---|---|---|
| BAX855 | BIOLOGICAL | Antihemophilic Factor (Recombinant), PEGylated |
INCLUSION CRITERIA Participants Transitioning from Other BAX 855 Studies: Participants transitioning from other BAX 855 studies can be provided with the continuation study informed consent form (ICF) prior to the end of study visit to review and consider participation in this continuation study. T...
BAX855 is an investigational therapy for Hemophilia A, a bleeding disorder. It is being developed as a treatment option for patients with this condition. The drug is currently in clinical development and has not been approved by regulatory authorities.
BAX855 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Hemophilia A.
BAX855 is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet received regulatory approval. The Phase 3 trial for BAX855 has been completed, and the results will inform potential next steps in its development.
BAX855 has one completed Phase 3 clinical trial registered under NCT01945593, titled "BAX 855 Continuation." This trial enrolled 218 participants with Hemophilia A across multiple countries, including the United States, Australia, Japan, and several European nations.
BAX855 is not known to have any alternative names. It is a distinct investigational drug being developed by Takeda for Hemophilia A. Patients and healthcare providers should refer to it by its official name, BAX855, when discussing clinical trials or treatment options.