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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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)

Brief 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

Detailed Summary:

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.

Sponsor: Ohio State University

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome: Same as current

Information By: Ohio State University

Dates:
Date Received: July 9, 2008
Date Started: November 2007
Date Completion: June 2017
Last Updated: January 13, 2017
Last Verified: January 2017