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Eltrombopag With Standard Immunosuppression for Severe Aplastic Anemia

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 86 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv86
  2. Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jan 30, 2029 to Nov 30, 2029
    • Site details revised
    v85
  3. 2 versions Re-verified since Nov 7, 2023, no change to tracked fieldsv83-v84
  4. Study completion date: Jan 30, 2024 to Jan 30, 2029v82
  5. 2 versions Re-verified since Jul 9, 2021, no change to tracked fieldsv80-v81
Show 43 earlier versionsHide 43 earlier versions
  1. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 92 to 207
    • Site details revised
    v79
  2. Results first posted: Jun 5, 2020v78 Show 8 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 207 to confirmed 92
    • Interventions: hATG/CsA /eltrombopag -Cohort 1 (Drug), hATG/CsA /eltrombopag Cohort 2 (Drug), hATG/CsA /eltrombopag Cohort 3 (Drug) to Cohort 1: hATG, CsA, EPAG Day 14 to Month 6 (Drug), Cohort 2: hATG, CsA, EPAG Day 14 to Month 3 (Drug), Cohort 3: hATG, CsA (dose reduced)…
    • Secondary endpoint revised
    • Site details revised
    • Publications: details revised at 1 of 12 entries
    • Collaborators expanded, about 1 word
  3. Re-verified, no change to tracked fieldsv77
  4. Primary completion date changed from estimate of Jan 30, 2020 to Jan 30, 2018
    • Secondary endpoints: details revised at 1 of 1 entry
    v76
  5. Re-verified, no change to tracked fieldsv75
  6. Enrollment target: 182 to 207
    • Interventions: hATG/CsA /eltrombopag -Cohort1 (Drug), hATG/CsA /eltrombopag Cohort 2 (Drug), hATG/CsA /eltrombopag Cohort 3 (Drug) to hATG/CsA /eltrombopag -Cohort 1 (Drug), hATG/CsA /eltrombopag Cohort 2 (Drug), hATG/CsA /eltrombopag Cohort 3 (Drug)
    v74
  7. 2 versions Re-verified since Mar 19, 2019, no change to tracked fieldsv72-v73
  8. Primary completion date: Jan 30, 2018 to Jan 30, 2020v71
  9. 3 versions Re-verified since Dec 14, 2018, no change to tracked fieldsv68-v70
  10. Primary completion date changed from estimate of Jan 30, 2019 to Jan 30, 2018
    • Start date: Jun 12, 2012 to Jul 2, 2012
    v67
  11. 4 versions Re-verified since Sep 1, 2018, no change to tracked fieldsv63-v66
  12. Interventions: Cyclosporine A (CSA) (Drug), Eltrombopag (Drug), Horse Anti-Thymocyte Globulin (ATG) (Drug) to hATG/CsA /eltrombopag -Cohort1 (Drug), hATG/CsA /eltrombopag Cohort 2 (Drug), hATG/CsA /eltrombopag Cohort 3 (Drug)
    • Secondary endpoint revised
    • Study arms: 0 to 4
    v62
  13. 4 versions Re-verified since May 8, 2018, no change to tracked fieldsv58-v61
  14. Site contact updatedv57
  15. Re-verified, no change to tracked fieldsv56
  16. Primary completion date: Jan 30, 2018 to Jan 30, 2019v55
  17. 4 versions Re-verified since Nov 25, 2017, no change to tracked fieldsv51-v54
  18. Enrollment target: 150 to 182v50
  19. Start date: Jun 7, 2012 to Jun 12, 2012v49
  20. 9 versions Re-verified since Jan 20, 2017, no change to tracked fieldsv40-v48
  21. Primary completion date: Jan 2018 to Jan 30, 2018
    • Study completion date: Jan 2024 to Jan 30, 2024
    • Start date: Jun 2012 to Jun 7, 2012
    v39
  22. 2 versions Re-verified since Dec 13, 2016, no change to tracked fieldsv37-v38
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: * Severe aplastic anemia is a rare and serious blood disorder. It happens when the immune system starts to attack the bone marrow cells. This causes the bone marrow to stop making red blood cells, platelets, and white blood cells. Standard treatment for this disease is horse-ATG and cyclosporine, which suppress the immune system and stop it from attacking the bone marrow. However, this treatment does not work in all people. Some people still have poor blood cell counts even after treatment. * Eltrombopag is a drug designed to mimic a protein in the body called thrombopoietin. It helps the body to make more platelets. It may also cause the body to make more red and white blood cells. Studies have shown that eltrombopag may be useful when added to standard treatment for severe aplastic anemia. It may help improve poor blood cell counts. Objectives: \- To test the safety and effectiveness of adding eltrombopag to standard immunosuppressive therapy for severe aplastic anemia. Eligibility: \- Individuals at least 2 years of age who have severe aplastic anemia that has not yet been treated. Design: * Participants will be screened with a physical exam, medical history, and blood tests. Blood and urine samples will be collected. * Participants will start treatment with horse-ATG and cyclosporine. Treatment will be given according to the standard of care for the disease. * Cohort 1: After 14 days, participants will start taking eltrombopag. They will take eltrombopag for up to 6 months. * Cohort 2: After 14 days, participants will start taking eltrombopag. They will take eltrombopag for up to 3 months. * Cohort 3 and Extension Cohort: Participants will start taking eltrombopag on Day 1. They will take eltrombopag for up to 6 months. * Participants may receive other medications to prevent infections during treatment. * Treatment will be monitored with frequent blood tests. Participants will also fill out questionnaires about their symptoms and their quality of life.
Trial Details
NCT Number NCT01623167
Lead Sponsor National Heart, Lung, and Blood Institute (NHLBI)
Collaborators: Novartis
Conditions
(from sponsor)		 Severe Aplastic Anemia
Related terms Anemia, Aplastic, Autoimmune Diseases, Pancytopenia, Thrombocytopenia
Enrollment 207 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov