Status:
UNKNOWN
Efficacy and Safety Study of Maintenance Treatment With rhTPO in Thrombocytopenic Subjects With ITP
Lead Sponsor:
Peking Union Medical College
Collaborating Sponsors:
Shenyang Sunshine Pharmaceutical Co., LTD.
Conditions:
Thrombocytopenia
Immune Thrombocytopenia
Eligibility:
All Genders
14-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of rhTPO in the maintenance treatment of ITP, to explore the appropriate dosing interval of the maintenance treatment of rhTPO .
Detailed Description
The eligible subjects with ITP firstly will receive a pre-treatment of rhTPO 300 IU/Kg once daily up to 14 days. The subjects with two consecutive platelet counts above 50×10\^9/L in the pre-treatment...
Eligibility Criteria
Inclusion
- Meeting the diagnostic criteria for immune thrombocytopenia (idiopathic thrombocytopenic purpura).
- Subject with resistance to or relapse after glucocorticoid in the treatment of ITP, not accepts splenectomy, or subject with ineffective or relapse after surgical splenectomy.
- Two consecutive platelet counts (not in the same day) \< 30×10\^9/L.
- Subject is willing and able to provide written informed consent.
Exclusion
- Pregnancy or breast feeding.
- Having a medical history of thrombosis.
- Significant abnormal cardio-pulmonary function.
- Abnormal liver and kidney function:
- a serum creatinine concentration≥ 176.8µmol/l (1.5mg/dl);
- a serum aminotransferase concentration: more than 2.0 times the upper limit of the normal range.
- a serum bilirubin concentration: more than 2.0 times the upper limit of the normal range.
- Synchronous tumor.
- Cannot adopt adequate contraceptive precautions during the course of the study.
- Any other treatment drugs for ITP are being taken (except the duration of reducing glucocorticoid dosage as ineffective treatment ).
- Any other situation that is not suitable for participating in the trial according to the judgment of the investigator .
Key Trial Info
Start Date :
February 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01805648
Start Date
February 1 2011
End Date
December 1 2013
Last Update
March 6 2013
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China