Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01178294 | Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A | PHASE2 | COMPLETED | 29 | — | — | Nov 10, 2010 | Oct 9, 2013 | May 13, 2021 | 12 | United States, Canada +2 |
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 ...