Efficacy and Safety of rHuTPO on Platelet Engraftment After Allo-HSCT
NCT ID: NCT01379391
Last Updated: 2015-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2010-06-30
Brief Summary
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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, it's 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, TPIAO)on platelet engraftment in Allo-HSCT in China.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TPO
Patients received myeloablative Allo-HSCT with platelet lower than 20G/L on +14d post-transplantation. Patient enrolled in TPO arm will recieved Recombinant Human Thrombopoietin (rHTPO) treatment fro 14 days.
Recombinant Human Thrombopoietin (rHTPO)
Patients received allogeneic myeloablative hematopoietic stem cell transplantation with platelet count lower than 20G/L on +14 days after Allo-HSCT, met the above enrollment criteria and signed the informed consent forms are eligible subjects.
Administration method of rHuTPO: 300U/kg/d by percutaneous injection; Timing: d14 to d28 after Allo-HSCT.
TPO-Free Arm
No TPO intervention
No interventions assigned to this group
Interventions
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Recombinant Human Thrombopoietin (rHTPO)
Patients received allogeneic myeloablative hematopoietic stem cell transplantation with platelet count lower than 20G/L on +14 days after Allo-HSCT, met the above enrollment criteria and signed the informed consent forms are eligible subjects.
Administration method of rHuTPO: 300U/kg/d by percutaneous injection; Timing: d14 to d28 after Allo-HSCT.
Eligibility Criteria
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Inclusion Criteria
2. Patients received myeloablative allogeneic hematopoietic stem cell transplantation from related or non-related, HLA compatible or incompatible donors. History controls or concurrent controls are used.
3. The platelet count is lower than 20G/L on +14d post-transplant .
4. The informed consent form has been signed.
Exclusion Criteria
2. Patients with severe cardio-cerebral diseases with over grade III A YHA cardiac function or with past history of coronary heart disease, cerebral thrombosis, cerebral arteriosclerosis, etc.
3. Patients with severe hepatic or renal dysfunction with more than 5 times the upper limit of normal range (ULN) of serum ALT or AST levels, or with more than 5 times the upper limit of normal range (ULN) of serum TBIL level or less than 40% of normal prothrombin time activity (PTA); or with more than 3 times the ULN of serum Cr.
4. Patients with history of deep vein thrombosis within 8 weeks of enrollment.
5. Patients with hepatic obstructive venous disease without recovery within 2 weeks of enrollment.
6. Patients with thrombotic microangiopathy without recovery within 2 weeks of enrollment.
7. Patients with capillary leaking syndrome without recovery within 2 weeks of enrollment.
8. Patients with other conditions considered unsuitable for the study.
9. Patients with hypercoagulopathy condition with two or more of these criteria: INR lower than 0.82, APTT lower than the lower limit of normal values (23 seconds) or PT lower than the lower limit of normal values (10 seconds).
18 Years
65 Years
ALL
No
Sponsors
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First Affiliated Hospital, Sun Yat-Sen University
OTHER
Third Affiliated Hospital, Sun Yat-Sen University
OTHER
Guangdong Provincial People's Hospital
OTHER
Guangdong No.2 Provincial People's Hospital
OTHER
Guangzhou General Hospital of Guangzhou Military Command
OTHER
Guangzhou Overseas Chinese Hospital,Guangdong
UNKNOWN
Zhongshan People's Hospital, Guangdong, China
OTHER
Southern Medical University, China
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Principal Investigators
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Jing Sun, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Hematology, Nanfang Hospital
Locations
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Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, China
Guangdong General Hospital
Guangzhou, Guangdong, China
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Guangdong No.2 Provincial People's Hospital
Guangzhou, Guangdong, China
Nanfang Hospital
Guangzhou, Guangdong, China
Guangzhou Overseas Chinese Hospital,Guangdong
Guangzhou, Guangdong, China
Third Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Zhongshan People Hospital,Guangdong
Zhongshan, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Website of Nanfang Hospital, Southern Medical University, Guangzhou, 510515, China.
Other Identifiers
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TPO-HSCT-2011
Identifier Type: -
Identifier Source: org_study_id
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