Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OBI-1 · 1 trial · 1 indication
The initial serious ("qualifying") bleeding episode for each subject was analyzed for the primary efficacy outcome measure. A 'positive response' is defined as 'effective' (bleeding stopped with clinical control and FVIII levels of 50% or higher ) or 'partially effective' (bleeding reduced with clinical stabilization and FVIII levels of 20% or higher) control of bleeding, as determined by the investigator using a 4-point rating scale (effective - partially effective - poorly effective - not effective). 'Poorly effective' is defined as 'bleeding slightly reduced or unchanged and FVIII levels of less than 50%'. 'Not effective' is defined as 'bleeding worsening and FVIII levels of less than 50%'.
| Arm | Type | Description |
|---|---|---|
| OBI-1 | EXPERIMENTAL | Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours) |
| Name | Type | Description |
|---|---|---|
| OBI-1 | BIOLOGICAL | Intravenous infusion |
Inclusion Criteria: * Written informed consent from subject, trusted person or person who is legally authorized to sign on behalf of the participant (Legal Representative in U.S.), depending on local regulations * Participants with acquired hemophilia with autoimmune inhibitory antibodies to human ...
OBI-1 is an investigational monoclonal antibody being studied for the treatment of Acquired Hemophilia A, a rare bleeding disorder. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
OBI-1 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker symbol TAK. The drug is currently in Phase 2 clinical trials for Acquired Hemophilia A.
OBI-1 is in Phase 2 clinical development. It is an investigational drug for Acquired Hemophilia A and has not yet received regulatory approval. One Phase 2 trial has been completed.
OBI-1 has one completed Phase 2 clinical trial, identified as NCT01178294, which studied the drug in subjects with Acquired Hemophilia A. The trial enrolled 29 participants across the United States, Canada, India, and the United Kingdom.
Yes, OBI-1 is a monoclonal antibody being developed for Acquired Hemophilia A. It is currently in Phase 2 clinical trials and is considered an investigational therapy.