immune thrombocytopenia
Conditions
Interventions
A (Zebitumumab: 375mg/m2 x once, Etamethasone tablets, 2.5-7.5mg, QD):None
B (Zebitumumab: 100mg/week, 4 times , Ethanolamine tablets, 2.5-7.5mg, QD):None
Sponsors
Pingdingshan First People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Voluntary signing of informed consent form; (2) Patients aged 18 years or older, regardless of gender, diagnosed with ITP; (3) ITP patients with ineffective first-line hormone therapy or hormone dependence; (4) Patients with platelet count<30 × 10^9/L or 30 × 10^9/L = platelet count<50 × 10^9/L accompanied by bleeding symptoms; (5) The subjects agreed to take effective contraceptive measures during the trial period and within 12 months after the end of the last medication.
Exclusion criteria
Exclusion criteria: (1) ITP patients with severe bleeding; (2) Active pulmonary tuberculosis and other uncontrolled active infections; (3) Participants who meet any contraindications specified in the labeling of Zebitumumab; (4) Individuals allergic to Zebitumumab; (5) Active infection of hepatitis B virus: patients with positive HBsAg or excessive copies of hepatitis B virus DNA; (6) Existence of angina pectoris, heart failure, myocardial infarction, severe arrhythmia, etc; (7) Received live vaccine within 4 weeks prior to screening; (8) Renal dysfunction, serum creatinine>1.5 times the upper limit of normal; (9) Abnormal liver function, AST or ALT>2.5 times the upper limit of normal values; (10) Suffering from cancer or having a history of cancer; (11) Suffering from a serious history of mental illness; (12) Received any other study drug within 20 days prior to receiving the first dose of the study drug, or within 5 times the half-life of the drug; (13) The doctor determines that participating in the study is not in line with the patient's rights or any other circumstances that prevent the safe implementation of the plan; (14) In the eyes of clinical doctors, other serious diseases that may limit participants' participation in this trial may prevent them from complying with research requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| platelet count ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;TBNK; | — |
Countries
China
Contacts
Public ContactZhanfang Wang
Pingdingshan First People's Hospital
Outcome results
None listed