Study to Evaluate Rituximab and Bortezomib in Patients With Newly Diagnosed Acquired Hemophilia A

• Status: Unknown status
• Trial end date: 2020-04-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Bortezomib; Factor VIII; Rituximab

Criteria

Inclusion Criteria:

1. Must be ≥ 18 years;

2. Understand and voluntarily sign an ICD prior to any study related assessments/procedures are conducted;

3. Diagnosis of acquired hemophilia A；

4. acute bleeding episodes(≥once).

Exclusion Criteria:

1. Uncontrolled systemic infection;

2. Allergy to rituximab;

3. Positive for Lupus anticoagulant;

4. Life expectancy < 3 months;

5. Pregnant and breastfeeding women;

6. Neuropathy>Grade 1;

7. Positive for Hepatitis B surface antigen or hepatitis C antibody or human immunodeficiency virus（HIV）antibody;

8. Patients with poor compliance；

9. Patient who is considered by the investigator not suitable for clinical study.