Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in Thrombotic Thrombocytopenic Purpura (TTP)

• Register: ClinicalTrials.gov
• Last refreshed on: 8 May 2023
• Main ID: NCT00713193
• Date of registration: 09/07/2008
• Prospective Registration: No
• Primary sponsor: Ohio State University
• Public title: Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in Thrombotic Thrombocytopenic Purpura (TTP)
• Scientific title: A Multi-Center, Randomized Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in the Initial Therapy of Thrombotic Thrombocytopenic Purpura (TTP)
• Date of first enrolment: November 2007
• Target sample size: 26
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00713193
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Spero R Cataland, MD
• Affiliation: Ohio State University

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Thrombotic Thrombocytopenic Purpura

Intervention(s)

Drug: Cyclosporine

Drug: Prednisone

Primary Outcome(s)

Number of Participants With Exacerbations in the CSA/PEX Arm Compared to the Steroids/PEX Arm [Time Frame: From the start of treatment until 30 days after discharge from the last PEX procedure]

Secondary Outcome(s)

Time in Days to Achieve a Clinical Response, Comparing the CSA/PEX Arm to the Steroids/PEX Arm. [Time Frame: Time to starting treatment until 6 months after the last PEX procedure]

Secondary ID(s)

2007H0194

R01FD003932

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Food and Drug Administration (FDA)

Results

• Results available: Yes
• Date Posted: 28/04/2023
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00713193