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
rhTPO
Cytopenia+15
+ Autoimmune Diseases
+ Blood Coagulation Disorders
Treatment Study
Summary
Study start date: February 1, 2011
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.120 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 14 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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 .
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Peking Union Medical College Hospital
Beijing, ChinaOpen Peking Union Medical College Hospital in Google Maps