Rituximab in Patients With Relapsed or Refractory TTP-HUS

Last updated: May 18, 2010
Sponsor: Hamilton Health Sciences Corporation
Overall Status: Trial Status Unknown

Phase

2

Condition

Thrombocytopenia And Thrombocytopenia Prevention

Kidney Failure (Pediatric)

Nephritis

Treatment

N/A

Clinical Study ID

NCT00531089
CAG-1
  • Ages > 18
  • All Genders

Study Summary

The general objective of this study is to assess the efficacy and safety of Rituximab in the management of patients with refractory or relapsed thrombotic thrombocytopenic purpura-hemolytic uremic syndrome (TTP-HUS). There have been several case reports and case series describing the use of Rituximab in patients with TTP-HUS; however its use has not been studied in a large trial. It is hypothesized that Rituximab may ameliorate the severity of certain cases of TTP-HUS by decreasing the number of activity of B-cells which may result in decreased production of the ADAMTS13 protease inhibitor. Patients with TTP-HUS not responding to standard therapy or patients with relapsed disease may have particular benefit. Treatments that decrease the frequency of relapse or shorten the time to remission of TTP-HUS will be of benefit by decreasing the need for blood product support.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • any patient 18 years or older diagnosed with relapsed or refractory TTP-HUS requiringtherapy

Exclusion

Exclusion Criteria:

  • alternate cause of hemolytic microangiopathy (evidence of DIC, malignant hypertension,vasculitis, anti-phospholipid antibody syndrome, post-partum acute renal failure)

  • congenital or familial TTP

  • TTP occuring post-stem cell, bone marrow, or solid organ transplant

  • drug-induced TTP

  • pregnancy or breast-feeding

  • history of hepatitis B or C infection

  • prior rituximab treatment

  • active or metastatic cancer

  • other causes of thrombocytopenia such as ITP, myelodysplastic syndrome, confirmed orsuspected drug-induced thrombocytopenia

  • refusal to receive blood products

  • hypersensitivity to blood products, plasma products, murine proteins, or any componentof the Rituximab formulation

  • geographic inaccessibility

  • co-morbid illness limiting life expectancy to less than 2 months independent of TTP

  • failure to provide written informed consent

Study Design

Total Participants: 60
Study Start date:
December 01, 2007
Estimated Completion Date:
January 31, 2011

Connect with a study center

  • Foothills Medical Centre, Calgary Health REgion Apheresis Service

    Calgary, Alberta T2N 2T9
    Canada

    Site Not Available

  • University of Alberta Hospital

    Edmonton, Alberta
    Canada

    Site Not Available

  • Vancouver General Hospital

    Vancouver, British Columbia V5Z1M9
    Canada

    Active - Recruiting

  • Winnipeg Regional Health Authority, Apheresis Department

    Winnipeg, Manitoba R3E 0T2
    Canada

    Site Not Available

  • St. John Regional Hospital

    St. John, New Brunswick E2K5S9
    Canada

    Site Not Available

  • Hamilton Health Sciences

    Hamilton, Ontario L8N 3Z5
    Canada

    Active - Recruiting

  • London Health Sciences Centre, Westminister Campus

    London, Ontario N6A4G5
    Canada

    Active - Recruiting

  • Princess Margaret Hospital, ABMT/Apheresis Unit

    Toronto, Ontario M5G2M9
    Canada

    Active - Recruiting

  • Hopital Charles Lemoyne

    Greenfield Park, Quebec
    Canada

    Site Not Available

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec H4J1C5
    Canada

    Site Not Available

  • St. Paul's Hospital Apheresis Unit

    Saskatoon, Saskatchewan S7M 0Z9
    Canada

    Active - Recruiting

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