deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT00713193

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

A Multi-Center, Randomized Study of Cyclosporine or Corticosteroids as an Adjunct to Plasma Exchange in the Initial Therapy of Thrombotic Thrombocytopenic Purpura (TTP)

Sponsor: Food and Drug Administration (FDA)

Updated 10 times since 2017 Last updated: Apr 29, 2023 Started: Nov 30, 2007 Primary completion: Sep 20, 2017 Completion: Sep 20, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Thrombotic Thrombocytopenic Purpura and is currently completed. Food and Drug Administration (FDA) leads this study, which shows 10 recorded versions since 2007 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Study Description(click to expand)

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.

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.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Oct 2017 · 8 months · monthly snapshotActive Not Recruiting~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~May 2023 · 28 months · monthly snapshotCompleted~May 2023 – ~Jun 2023 · 31 days · monthly snapshotCompleted~Jun 2023 – ~Jul 2024 · 13 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

10 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Present [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jun 2023 — Jul 2024 [monthly]

    Completed PHASE3

  5. May 2023 — Jun 2023 [monthly]

    Completed PHASE3

Show 5 earlier versions
  1. Jan 2021 — May 2023 [monthly]

    Completed PHASE3

  2. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE3

  3. Oct 2017 — Jun 2018 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  4. Feb 2017 — Oct 2017 [monthly]

    Active Not Recruiting PHASE3

  5. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Nov 2007

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Food and Drug Administration (FDA)
  • Ohio State University
Data source: Ohio State University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations