Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY Factor VII · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| BAY Factor VII (6.5 µg/kg) / Placebo | EXPERIMENTAL | n = 4, randomized 3:1; 6.5 µg/kg BAY 86-6150 (B0189):Placebo |
| BAY Factor VII (20 µg/kg) / Placebo | EXPERIMENTAL | n = 4, randomized 3:1; 20 µg/kg BAY 86-6150 (B0189):Placebo |
| BAY Factor VII (50 µg/kg) / Placebo | EXPERIMENTAL | n = 4, randomized 3:1; 50 µg/kg BAY 86-6150 (B0189):Placebo |
| BAY Factor VII (90 µg/kg) / Placebo | EXPERIMENTAL | n = 4, randomized 3:1; 90 µg/kg BAY 86-6150 (B0189):Placebo |
| Name | Type | Description |
|---|---|---|
| BAY Factor VII (BAY86-6150) | DRUG | BAY Factor VII (BAY86-6150), 6.5 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1. |
| Placebo | DRUG | Placebo will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1. |
Inclusion Criteria: * History of moderate or severe congenital hemophilia A or B with or without inhibitors to Factor VIII (FVIII) or Factor IX (FIX) * Male subjects 18-65 years of age inclusive * Able to dismiss factor replacement therapy during the course of the study unless required for the trea...
BAY Factor VII is an investigational small molecule being developed for hemophilia A. It is a factor VIIa variant studied in subjects with moderate or severe hemophilia types A or B, with or without inhibitors. The drug is in Phase 1 clinical development and is not yet approved.
BAY Factor VII is being developed by Bayer AG, a German pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker BAYRY. The drug is currently in Phase 1 clinical development for hemophilia A.
BAY Factor VII is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains in early-stage clinical development for hemophilia A.
BAY Factor VII has one completed Phase 1 clinical trial, identified as NCT01921855. This study evaluated the FVIIa variant BAY86-6150 (B0189) in 16 male subjects aged 18 years and older with moderate or severe hemophilia A or B, with or without inhibitors. The trial was conducted in Poland, South Africa, and the United Kingdom.
Yes, BAY Factor VII is also known as BAY86-6150, and the clinical trial refers to it as the FVIIa variant B0189. In the Phase 1 study NCT01921855, the drug is described as BAY86-6150 (B0189), indicating these names refer to the same investigational factor VIIa variant.