Efficacy and Safety Study of Maintenance Treatment With rhTPO in Thrombocytopenic Subjects With ITP

• Status: Unknown status
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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 .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College
• Collaborator: Shenyang Sunshine Pharmaceutical Co., LTD.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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 .