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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 being developed for the treatment of acquired hemophilia A, a rare bleeding disorder in which patients develop antibodies that inhibit their own clotting factor VIII. It is an investigational monoclonal antibody studied in adults aged 18 years and older.
OBI-1 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program evaluating the therapy in acquired hemophilia A.
OBI-1 is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 2 program has been completed, and no trials of OBI-1 are currently active.
OBI-1 has been studied in one Phase 2 clinical trial, NCT01178294, titled a Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A. The trial enrolled 29 adults, was uncontrolled and non-randomized, and has been completed. It ran in the United States, Canada, India, and the United Kingdom.
OBI-1 is a monoclonal antibody being developed as a treatment for acquired hemophilia A. It was studied as a modified recombinant factor VIII therapy in adults with the condition, a bleeding disorder driven by inhibitory antibodies against factor VIII.