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

Peking Union Medical College120 enrolled

Overview

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 .

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

120

Conditions

Thrombocytopenia Immune Thrombocytopenia Idiopathic Thrombocytopenic Purpura

Interventions

rhTPODRUG

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.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 70 Years

Medical Language ↔ Plain English

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 .

Locations (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

Outcomes

Primary Outcomes

The effective rate of maintenance treatment (the platelet count continued to be over 30 × 10^9/L)

Time frame: up to 16 weeks per subject

Secondary Outcomes

The effective rate of maintenance treatments adopting different frequency of administration

Time frame: up to 16 weeks per subject

Number of subjects with Adverse Events as a Measure of Safety

Time frame: up to 18 weeks per subject

Central Contacts

Yongqiang Zhao, Dr.

CONTACT

535114726@qq.com

Shujie Wang

CONTACT

yangwl2007@yahoo.cn

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.