Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Carelon Research
Study ID
NCT00799773
Phase
PHASE3
Status
Terminated

Conditions

  • Thrombotic Thrombocytopenic Purpura

Eligibility Criteria

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

Interventions

  • Rituximab — DRUG
    Dose of 375 mg/m2, given intravenously, repeated at 1-week intervals for a total of four doses
  • Plasma exchange — PROCEDURE
    Target volume of 1.25 plasma volume replacement; fresh frozen plasma (FFP) is the required replacement fluid; provided daily until platelet counts are normal and signs of tissue damage have improved.
  • Corticosteroids — DRUG
    1 mg/kg of prednisone (or equivalent) each day until plasma exchange is stopped

Study Details

Thrombotic thrombocytopenic purpura (TTP) is a rare disorder that causes blood clots to form in blood vessels. The main treatment for TTP is plasma exchange, in which affected patients receive transfusions of plasma, the liquid part of blood, from healthy donors. This study will examine the effectiveness of an antibody, rituximab, in combination with plasma exchange, at improving the immune response in people with TTP and decreasing the recurrence of TTP.

Key Dates

Start date
Apr 30, 2009
Status verified
Jul 2013
Primary completion
Feb 28, 2010
Completion
Feb 28, 2010

Study Design

Enrollment
3 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
    Participants will receive rituximab in addition to plasma exchange and corticosteroids.
  • Active Comparator: 2
    Participants will receive plasma exchange and corticosteroids.

Primary Outcome Measure

Role of Rituximab in Increasing Early Treatment Response in Participants With TTP Who Are Also Treated With Plasma Exchange and Corticosteroids [ Time Frame: Measured at Day 52 ]

Locations (23)

FacilityCityStateZIPSite coordinators
University of Alabama, BirminghamBirminghamAlabama35249-
Emory UniversityAtlantaGeorgia30322-
University of IowaIowa CityIowa52242-
Tulane University Health Sciences CenterNew OrleansLouisiana70112-
Johns Hopkins HospitalBaltimoreMaryland21205-
University of Maryland Medical CenterBaltimoreMaryland21201-
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Brigham and Women's HospitalBostonMassachusetts02115-
Children's Hospital BostonBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-
New York-Presbyterian Hospital/Weill Cornell Medical CenterNew YorkNew York10021-
University of North Carolina HospitalsChapel HillNorth Carolina27514-
Duke University Medical CenterDurhamNorth Carolina27710-
University Hospital ClevelandClevelandOhio44106-
Integris Baptist Medical CenterOklahoma CityOklahoma73112-
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73104-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Children's Hospital of PittsburghPittsburghPennsylvania15213-
University of Pittsburgh Presbyterian and Shadyside HospitalPittsburghPennsylvania15213-
Puget Sound Blood CenterSeattleWashington98104-
Gunderson Clinic, LTDLa CrosseWisconsin54601-
University of Wisconsin at MadisonMadisonWisconsin53792-
Froedtert Memorial Lutheran HospitalMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By research site
University of Alabama, Birmingham· Birmingham, ALEmory University· Atlanta, GAUniversity of Iowa· Iowa City, IATulane University Health Sciences Center· New Orleans, LAJohns Hopkins Hospital· Baltimore, MDUniversity of Maryland Medical Center· Baltimore, MD

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