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

NCT ID: NCT01805648

Last Updated: 2013-03-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-12-31

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 period will begin to receive maintenance treatment of rhTPO 300 IU/Kg for 12 weeks. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30 ×10^9/L～100 ×10^9/L. Subsequently, subjects will stop treatment of rhTPO and be followed up for 4 weeks after maintenance treatment.

Platelet count, bleeding and other symptoms will be evaluated before and after treatment.

Platelet transfusion will be administered to subjects with active bleeding symptoms.

Toxicity will be monitored continuously during the entire study. Safety will be assessed by adverse events and laboratory tests.

Conditions

Thrombocytopenia; Immune Thrombocytopenia; Idiopathic Thrombocytopenic Purpura

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rhTPO

Active investigational product

Group Type: EXPERIMENTAL

rhTPO

Intervention Type: DRUG

Subcutaneously dosing of rhTPO is based on screening weight. Subjects will be given rhTPO 300 IU/Kg once daily up to 14 days in the pre-treatment period . When two consecutive platelet counts is above 50×10\^9/L, the subjects will be begin to receive maintenance treatment of rhTPO 300 IU/Kg. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30×10\^9/L～100×10\^9/L.

Interventions

rhTPO

Subcutaneously dosing of rhTPO is based on screening weight. Subjects will be given rhTPO 300 IU/Kg once daily up to 14 days in the pre-treatment period . When two consecutive platelet counts is above 50×10\^9/L, the subjects will be begin to receive maintenance treatment of rhTPO 300 IU/Kg. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30×10\^9/L～100×10\^9/L.

Intervention Type: DRUG

Other Intervention Names

Recombinant Human Thrombopoietin; Recombinant Human TPO

Eligibility 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 .

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shenyang Sunshine Pharmaceutical Co., LTD.

INDUSTRY

Sponsor Role: collaborator

Peking Union Medical College

OTHER

Sponsor Role: lead

Responsible Party

Yongqiang Zhao

The Director of Hematology Department of Peking Union Medical College Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yongqiang Zhao, Dr.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College

Locations

Peking Union Medical College Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Yongqiang Zhao, Dr.

Role: CONTACT

535114726@qq.com

Shujie Wang

Role: CONTACT

yangwl2007@yahoo.cn

Facility Contacts

Shujie Wang, Dr.

Role: primary

yangwl2007@yahoo.cn

Other Identifiers

TPOzyq120725

Identifier Type: -

Identifier Source: org_study_id