Low Dose Rituximab in Thrombotic Thrombocytopenic Purpura

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Washington University School of Medicine
Study ID
NCT01554514
Phase
PHASE2
Status
Completed

Conditions

  • Thrombotic Thrombocytopenic Purpura

Eligibility Criteria

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

Interventions

  • rituximab — BIOLOGICAL
    rituximab intravenously 100 mg every week for four doses

Study Details

Thrombotic thrombocytopenic purpura (TTP) is a disease characterized by small blood clots throughout the body that can damage major organs and cause death. TTP is treated with plasma exchange (also called "plasmapheresis"). Patients who do not respond initially to plasma exchange often are helped by later treatment with rituximab. The purpose of this study is to see whether combining low doses of rituximab with plasma exchange will help patients get better sooner and reduce the chance of getting TTP again.

Key Dates

Start date
Aug 31, 2012
Status verified
Aug 2021
Primary completion
Feb 14, 2020
Completion
Feb 14, 2020

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: low dose rituximab
    this is a single-arm trial

Primary Outcome Measure

Incidence of the Composite Primary Outcome of Exacerbation or Refractory TTP [ Time Frame: 60 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
Emory UniversityAtlantaGeorgia30322-
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Washington UniversitySt LouisMissouri63110-
Duke University Medical CenterDurhamNorth Carolina27710-

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