Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in Thrombotic Thrombocytopenic Purpura (TTP)
|Thrombotic Thrombocytopenic Purpura||Drug: Cyclosporine Drug: Prednisone||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official 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)|
- To determine if CSA given individually as an adjunct to PE decreases the frequency of exacerbation in patients with TTP compared to those patients given corticosteroids as an adjunct to PE. [ Time Frame: 30 days ]
- To compare the CSA and PE-treated patients to the corticosteroid and PE-treated patients in terms of the number of exchange procedures to achieve clinical remission and the relapse rate after tapering the adjuvant immune-based therapy. [ Time Frame: 2-5 years ]
|Study Start Date:||November 2007|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
Patients in this arm will receive cyclosporine (Neoral) at a dose of 2-3 mg/kg orally as an adjunct to plasma exchange.
2-3 mg/kg orally in a twice day divided dose for 6 months
Other Name: Neoral
Active Comparator: 2
Patients in this arm will receive prednisone at a dose of 1 mg/kg as an adjunct to plasma exchange.
1 mg/kg orally, daily for at least 30 days, then tapered over 30 days after achieving remission.
TTP is a rare blood disorder that causes blood clots to form in the small blood vessels throughout the body, including the kidneys, brain, abdomen, and the heart. Plasma exchange is the standard treatment for TTP. Plasma exchange is a treatment that removes the plasma (the liquid portion of the blood without any cells) from a patient and replaces it with plasma from a donor. With plasma exchange, 90% of patients achieve a remission of the disease. Unfortunately, up to one half of patient will relapse after the plasma exchange has stopped, leading to significant complications and added risks to the patient.
This study randomizes patients to receive either prednisone or cyclosporine as an adjunct to plasma exchange, with the cyclosporine arm being the experimental arm of the study. All patients will undergo plasma exchange but will be randomized to receive either prednisone or cyclosporine as an adjunct to plasma exchange. Previous studies suggested that cyclosporine was superior to prednisone as an adjunct to plasma exchange, and therefore this randomized study attempts to confirm the findings of two previous single institution studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713193
|United States, Ohio|
|Ohio State University|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Spero R Cataland, MD||Ohio State University|