At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 26 enrolled
Drug / intervention
Cyclosporine +1 moredrug
Likely dose
Cyclosporine 3 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Randomized Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in the Initial Therapy of Thrombotic Thrombocytopenic Purpura (TTP)
In Brief
A Phase 3 clinical trial evaluating Cyclosporine and Prednisone for Thrombotic Thrombocytopenic Purpura. Completed, enrolled 26 participants across 1 site.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombotic Thrombocytopenic Purpura
CountriesUnited States
CollaboratorsFood and Drug Administration (FDA)
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
First PostedJul 2008
Primary CompletionSep 2017
TodayJul 2026
First PostedJul 11, 2008
Enrollment StartNov 1, 2007
Primary CompletionSep 20, 2017
TodayJul 2, 2026
Enrollment to primary: 9.9 yearsPosted 18.0 years ago
Interventions
Cyclosporinedrug
2-3 mg/kg orally in a twice day divided dose for 6 months
Prednisonedrug
1 mg/kg orally, daily for at least 30 days, then tapered over 30 days after achieving remission.