Newly diagnosed severe ITP
Conditions
Interventions
Experimental group:Glucocorticoid combined with gamma globulin and Romiplostim N01
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Sign written informed consent before enrollment; 2. Age 18-75 years old; 3. Platelet count < 10×10^9/L with active bleeding, or bleeding score =5 points; 4. No contraindications in the use of hormones, Romiplostim and IVIG, and willing to accept the above drug treatment; 5. No prior splenectomy or at least one first-line ITP treatment or emergency treatment; 6. Did not receive Romiplostim treatment; 7. ECOG PS score: 0 ~ 2; 8. Subjects of reproductive age who agree to use reliable contraceptive methods (including male or female condoms, contraceptive foam, contraceptive gel, contraceptive film, contraceptive paste, contraceptive suppost, abstinence from sex and placement of Iuds) throughout the study period; Excluding female subjects who have undergone hysterectomy, bilateral fallopian tube resection, bilateral fallopian tube ligation or more than 1 year postmenopausal, and male subjects who have undergone bilateral vasectomy or ligation; 9. Voluntary participation in this study, good compliance.
Exclusion criteria
Exclusion criteria: 1. Suffering from the following hematopoietic diseases other than ITP, including but not limited to leukemia, tumor treaty-induced thrombocytopenia, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome; 2. Patients with history of thrombosis; 3. Pregnant or breastfeeding; 4. Severe cardiopulmonary insufficiency; 5. Severe or difficult to control infection; 6. Infected; 7. Unable to comply due to mental reasons; 8. The investigator judged that it is not suitable to participate in this experiment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 30 days of treatment, the total effective rate GR=CR+R (complete response to CR, platelet count =100×10^9/L, and no bleeding symptoms; Effective R, with a platelet count between 30×10^9/L and 100×10^9/L, and at least a 2 times of increase from the baseline, and no bleeding symptoms); | — |
Secondary
| Measure | Time frame |
|---|---|
| Early (1 week) response rate R;Early complete response rate CR;To response time (time from initiation of treatment to platelet count =30×10^9/L);Adverse events during treatment; | — |
Countries
China
Contacts
Public ContactHu Yu
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Outcome results
None listed