Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in Thrombotic Thrombocytopenic Purpura (TTP)
Condition: Thrombotic Thrombocytopenic Purpura
MeSH terms: Purpura; Purpura, Thrombocytopenic; Purpura, Thrombotic Thrombocytopenic
Intervention: Cyclosporine; Prednisone
Intervention description: 2-3 mg/kg orally in a twice day divided dose for 6 months; 1 mg/kg orally, daily for at least 30 days, then tapered over 30 days after achieving remission.
Intervention MeSH terms: Cyclosporine; Prednisone; Cyclosporins
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Idiopathic TTP; Treatment; Exacerbation; Relapse; Plasma Exchange

Summary:

      This research involves the use of immune base therapy as an adjunct to plasma exchange, the
      present standard of care for thrombotic thrombocytopenic purpura (TTP). Funding source -FDA
      OOPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a clinical diagnosis of idiopathic TTP as defined by a microangiopathic
             hemolytic anemia and thrombocytopenia (<100 x 103)

          -  Additional components of the pentad (fever, renal and neurologic abnormalities) need
             not be present.

          -  Additional explanations for the microangiopathic changes including DIC and malignancy
             should be excluded.

          -  Patients with pregnancy associated TTP will be permitted on this therapeutic trial if
             the child is delivered prior to the initiation of therapy for TTP. However, female
             patients that are breastfeeding and are unwilling to discontinue breastfeeding at the
             time of enrollment will be excluded from this study

          -  Patients with a previous diagnosis of TTP are eligible to be enrolled provided they
             meet eligibility criteria and have not been treated for an TTP in the past 30 days

          -  Given the potential for nephrotoxicity with CSA, all patients must have a serum
             creatinine of < 2.5 mg/dl prior to enrollment

        Exclusion Criteria:

          -  In light of concern for the prompt initiation of PE, all patients with suspected TTP
             may be enrolled on this trial. If it is subsequently found that the patient does not
             meet enrollment criteria, they will be removed and their spot replaced for study
             purposes. Patients removed from the study after enrollment will continue to be
             followed longitudinally for 6 months to be monitored for safety and will be included
             in the safety database.

          -  Patients with TTP clinically categorized as secondary to stem cell transplant and
             solid organ, bloody diarrhea associated, malignancy associated, and drug associated
             will not be enrolled on this therapeutic study.

          -  Incarcerated patients will be excluded from the study due to the inherent difficulties
             in maintaining close follow-up for study purposes in patients who are incarcerated.

          -  Any patients already being treated chronically with corticosteroids or cyclosporine
             and taking these at the time of their presentation will be excluded from this study.

          -  Female patients that are breastfeeding and are unwilling to discontinue breastfeeding
             at the time of enrollment will be excluded from this study

          -  Patients taking any medications contraindicated in combination with CSA that cannot be
             safely discontinued will be excluded from this study.