Clinical Trial: Efficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic Anemia

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Efficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic Anemia

Brief Summary: Efficacy and Safety of Recombinant human thrombopoietin in patients with severe aplastic anemia and very severe aplastic anemia, a randomized, double-blind, placebo-controlled, II phase, multi-center clinical research.

Detailed Summary: rhTPO
Sponsor: Tianjin Medical University General Hospital

Current Primary Outcome: Time to platelet transfusion independence in patients at 6 month [ Time Frame: 6 month ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to patients achieve a platelet count 30×10^9/L, 50×10^9/L or100×10^9/L [ Time Frame: up to 1year ]
  • Overall response rate up to 1 year after Immunosupressive therapy. [ Time Frame: up to 1 year ]
  • Megakaryocyte, granulocyte and erythrocyte recovery in bone marrow up to 1 year after IST. [ Time Frame: up to 1 year ]
  • Time to red blood cell/platelet transfusion independence in patients up to 1 year after IST [ Time Frame: up to 1 year ]
  • Percentage of patients achieve red blood cell/platelet transfusion independence at 3, 6, 9 and 12 months after IST. [ Time Frame: up to 1 year ]
  • Intervals of red blood cell/platelet transfusion up to 1 year after IST. [ Time Frame: up to 1 year ]
  • The reticulocyte count of patients up to 1 year after IST. [ Time Frame: up to 1 year ]
  • Hospitalization days of patients. [ Time Frame: up to 1 year ]
  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: up to 1 year ]
  • Median hematopoietic response rate up to 1 year after IST. [ Time Frame: up to 1 year ]


Original Secondary Outcome: Same as current

Information By: Tianjin Medical University General Hospital

Dates:
Date Received: July 26, 2016
Date Started: August 2016
Date Completion: July 2020
Last Updated: August 4, 2016
Last Verified: August 2016