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

Thrombocytopenia Clinical Trial

Official title:

A Multicenter, Single-Arm, Open Label Study Evaluating the Efficacy and Safety of Maintenance Treatment With Recombinant Human Thrombopoietin in Thrombocytopenic Subjects With Immune Thrombocytopenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01805648
• Other study ID #: TPOzyq120725
• Status: Recruiting
• Phase: Phase 3
• First received: February 22, 2013
• Last updated: March 4, 2013
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: March 2013
• Source: Peking Union Medical College
• Contact: Yongqiang Zhao, Dr.
• Email: 535114726[@]qq.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 70 Years

Eligibility

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 .

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Idiopathic Thrombocytopenic Purpura
• Immune Thrombocytopenia
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia
• Thrombocytosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effective rate of maintenance treatment (the platelet count continued to be over 30 × 10^9/L)		up to 16 weeks per subject	No
Secondary	The effective rate of maintenance treatments adopting different frequency of administration		up to 16 weeks per subject	No
Secondary	Number of subjects with Adverse Events as a Measure of Safety		up to 18 weeks per subject	Yes