Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAX 888 · 1 trial · 1 indication
An AE is defined as any untoward medical occurrence in a participant administered an investigational product (IP) that does not necessarily have a causal relationship with the treatment. A Serious adverse event (SAE) is an AE resulting in any of the following outcomes: death; life-threatening event; required or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. AEs include both serious and non-serious adverse events including development of FVIII inhibitory antibodies, clinically significant changes in standard laboratory parameters, physical exam, and vital signs.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: BAX 888 2.0*10^12 cp/kg | EXPERIMENTAL | Cohort 1 participants received a single peripheral intravenous (IV) infusion of BAX 888 at a dose of 2.0\*10\^12 capsid particles per kilogram (cp/kg) on the day of dosing (Day 0). |
| Cohort 2: BAX 888 6.0*10^12 cp/kg | EXPERIMENTAL | Cohort 2 participants received a single peripheral IV infusion of BAX 888 at a dose of 6.0\*10\^12 cp/kg on the day of dosing (Day 0). |
| Name | Type | Description |
|---|---|---|
| BAX 888 | DRUG | Participants will receive a single peripheral IV infusion of BAX 888 in Cohort 1 and 2 Day 0. |
Inclusion Criteria: * Male, aged 18 to 75 years at the time of screening. * Established severe hemophilia A (FVIII:C \<1%, measured following \>=5 days without FVIII treatment) and/or documented intron 1 inversion or intron 22 inversion mutation in the F8 gene, consistent with severe hemophilia A ,...
BAX 888 is an investigational small molecule being developed for the treatment of hemophilia A, a bleeding disorder. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
BAX 888 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with hemophilia A.
BAX 888 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved for commercial use. The Phase 1 trial has been completed, and the drug remains under investigation for hemophilia A.
BAX 888 has one completed Phase 1 clinical trial registered as NCT03370172, titled 'A Study of BAX 888 in Male Adults With Severe Hemophilia A.' The trial enrolled 4 participants and was conducted in the United States, Austria, France, Germany, Hungary, and Spain.
No alternative names for BAX 888 have been disclosed. The drug is identified solely by its code name BAX 888 in clinical trial registrations and development documentation.