Ignite Creation Date:
2024-05-05 @ 11:37 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01379391
Status:
UNKNOWN
Last Update Posted:
2015-10-09
First Post:
2011-06-20
Brief Title:
Efficacy and Safety of rHuTPO on Platelet Engraftment After Allo-HSCT
Sponsor:
Nanfang Hospital Southern Medical University
Organization:
Nanfang Hospital Southern Medical University
Study Overview
Official Title:
A Phase IV Open-label Prospective Multicenter Study of the Efficacy and Safety of Recombinant Human Thrombopoietin Injection rHuTPO TPIAOon Platelet Engraftment in Allogeneic Hematopoietic Stem Cell Transplantation in China
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TPO
Brief Summary:
Factors influencing platelet engraftment after allogeneic hematopoietic stem cell transplantation Allo-HSCT includes previous chemotherapy courses conditioning regimen HLA compatibility source of stem cell CD34 cell count infection of virusbacteriafungal graft-versus-host disease GVHD etc Large-scaled clinical trials have demonstrated that platelet count below 20GL on 14 days after transplantation is an predictive factor for delayed platelet engraftment which lead to increased platelet infusion requirement and high risk of bleeding Multivariable survival analysis indicated that delayed platelet engraftment in Allo-HSCT is independent predictive factor for transplantation related mortality TRM But effective treatment approaches for delayed platelet recovery after Allo-HSCT are still lacking now
Recombinant human thrombopoietin rHuTPO is a fully modified recombinant human thrombopoietin accurately expressed in mammalian cells The rHuTPO agent manufactured by the 3Bio Pharmaceutical Limited Liability Company LLC in Shenyang is approved by the State Food and Drug Administration SFDA of China in 2005 and is the first rHuTPO agent available globally RHuTPO was approved for for immune thrombocytopenia and chemotherapy-related thrombocytopenia in China Animal experiments showed that TPO-mobilizing stem cell could promote platelet engraftment in Allo-HSCT in mice As for efficacy and safety of TPO on platelet engraftment after Allo-HSCT its marginally addressed in clinical trials
Based on preliminary research results investigator designed a phase IV open-label prospective multicenter Study of the efficacy and safety of recombinant human thrombopoietin injection rHuTPO TPIAOon platelet engraftment in Allo-HSCT in China
Recombinant human thrombopoietin rHuTPO is a fully modified recombinant human thrombopoietin accurately expressed in mammalian cells The rHuTPO agent manufactured by the 3Bio Pharmaceutical Limited Liability Company LLC in Shenyang is approved by the State Food and Drug Administration SFDA of China in 2005 and is the first rHuTPO agent available globally RHuTPO was approved for for immune thrombocytopenia and chemotherapy-related thrombocytopenia in China Animal experiments showed that TPO-mobilizing stem cell could promote platelet engraftment in Allo-HSCT in mice As for efficacy and safety of TPO on platelet engraftment after Allo-HSCT its marginally addressed in clinical trials
Based on preliminary research results investigator designed a phase IV open-label prospective multicenter Study of the efficacy and safety of recombinant human thrombopoietin injection rHuTPO TPIAOon platelet engraftment in Allo-HSCT in China
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None