Acquired Hemophilia A Clinical Trial
Official title:
An Open-label Phase II Study to Determine the Efficacy and Safety of Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia A
The purpose of this prospective study is to determine the efficacy and safety of Rituximab plus Bortezomib in patients with newly diagnosed acquired hemophilia A.
This is a prospective, single-arm, open-label clinical trial to evaluate the efficacy and
safety the regimen of Bortezomib with rituximab as first-line treatment to eradicate
anti-factor VIII antibodies in newly diagnosed acquired hemophilia A.
All of enrolled patients in this study will be injected Bortezomib plus rituximab. This study
will be performed for about 2 years and approximately 22 patients will be enrolled in our
insititution.
After obtaining the written informed consent from the patients, the information of
demographic and medical history will be collected and laboratory tests will be performed.
Patients who meet the inclusion/exclusion criteria will be received the regimens: Bortezomib
(1.3mg/m2 d1,4,8,11) with rituximab (375mg/m2 for one dose). The information of adverse
events will be collected. In case that the evaluation of treatment response might be
performed in regular clinical practice, those data will also be collected as well.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04580407 -
Study of TAK-672 in Participants With Acquired Hemophilia A
|
Phase 2/Phase 3 | |
| Completed |
NCT01178294 -
Study of Modified Recombinant Factor VIII (OBI-1) in Subjects With Acquired Hemophilia A
|
Phase 2/Phase 3 | |
| Recruiting |
NCT06461533 -
A Survey of Susoctocog Alfa (Genetical Recombination) in Participants With Acquired Haemophilia A
|
||
| Completed |
NCT02610127 -
Post-Marketing Non-Interventional Safety Evaluation of Obizur in the Treatment of Bleeding Episodes for Patients With Acquired Hemophilia A
|
||
| Completed |
NCT03384277 -
Trial of Acquired Haemophilia With Steroid Combined With Cyclophosphamide Versus Steroid Combined With Rituximab
|
Phase 4 | |
| Completed |
NCT03199794 -
Prospective and Retrospective, Non-interventional Study to Evaluate the Safety and Effectiveness of Obizur in Real-life Practice
|
||
| Recruiting |
NCT05345197 -
Emicizumab in Patients With Acquired Hemophilia A
|
Phase 2 | |
| No longer available |
NCT01968655 -
Expanded Access to B-Domain Deleted Recombinant Porcine Factor VIII (OBI-1) in the Treatment of Acquired Hemophilia A Due to Factor VIII Inhibitory Auto-antibodies
|