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

PHASE3TerminatedINTERVENTIONAL
Enrollment

3

Participants

Timeline

Start Date

April 30, 2009

Primary Completion Date

February 28, 2010

Study Completion Date

February 28, 2010

Conditions
Thrombotic Thrombocytopenic Purpura
Interventions
DRUG

Rituximab

Dose of 375 mg/m2, given intravenously, repeated at 1-week intervals for a total of four doses

PROCEDURE

Plasma exchange

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.

DRUG

Corticosteroids

1 mg/kg of prednisone (or equivalent) each day until plasma exchange is stopped

Trial Locations (23)

10021

New York-Presbyterian Hospital/Weill Cornell Medical Center, New York

15213

Children's Hospital of Pittsburgh, Pittsburgh

University of Pittsburgh Presbyterian and Shadyside Hospital, Pittsburgh

19104

University of Pennsylvania, Philadelphia

21201

University of Maryland Medical Center, Baltimore

21205

Johns Hopkins Hospital, Baltimore

27514

University of North Carolina Hospitals, Chapel Hill

27710

Duke University Medical Center, Durham

30322

Emory University, Atlanta

35249

University of Alabama, Birmingham, Birmingham

44106

University Hospital Cleveland, Cleveland

52242

University of Iowa, Iowa City

53226

Froedtert Memorial Lutheran Hospital, Milwaukee

53792

University of Wisconsin at Madison, Madison

54601

Gunderson Clinic, LTD, La Crosse

70112

Tulane University Health Sciences Center, New Orleans

73104

University of Oklahoma Health Sciences Center, Oklahoma City

73112

Integris Baptist Medical Center, Oklahoma City

98104

Puget Sound Blood Center, Seattle

02114

Massachusetts General Hospital, Boston

02115

Beth Israel Deaconess Medical Center, Boston

Brigham and Women's Hospital, Boston

Children's Hospital Boston, Boston

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

collaborator

Genentech, Inc.

INDUSTRY

lead

Carelon Research

OTHER

NCT00799773 - Evaluating the Effectiveness of Adding Rituximab to Standard Treatment for Thrombotic Thrombocytopenic Purpura (TTP) | Biotech Hunter | Biotech Hunter