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Clinical Trial Summary

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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03700229
Study type Interventional
Source Peking Union Medical College Hospital
Contact Huacong Cai
Phone 01069158271
Email caihc@pumch.cn
Status Recruiting
Phase Phase 2
Start date October 10, 2018
Completion date April 15, 2020

See also
  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
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