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

Sponsor
Peking Union Medical College Hospital
Study ID
NCT03700229
Phase
PHASE2
Status
Unknown

Conditions

  • Acquired Hemophilia A

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bortezomib — DRUG
    Bortezomib intravenously 1.3mg/m2 d1,4,8,11 for 4 doses
  • Rituximab — DRUG
    rituximab intravenously 500 mg for one dose

Study Details

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.

Key Dates

Start date
Oct 10, 2018
Status verified
Nov 2018
Primary completion
Oct 15, 2019
Completion
Apr 15, 2020

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bortezomib +Rituximab
    Bortezomib +Rituximab

Primary Outcome Measure

The time to attain first complete remission (CR) [ Time Frame: Last day of the treatment regimen (up to 3 months) ]

Central Contacts