Primary Immune Thrombocytopenia
Conditions
Keywords
severe ITP, Romiplostim
Brief summary
The goal of this clinical trial is to learn if romiplostim N01 works to treat severe primary immune thrombocytopenia in adults. It will also learn about the safety of romiplostim N01. The main question it aims to answer is: TO evaluate the effectiveness of the combination treatment of glucocorticoids, gamma globulin and romiplostim N01 in patients with severe primary immune thrombocytopenia during the initial treatment period for one month. Participants will: Romiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month. IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days. Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.
Interventions
DRUGcorticosteroids combined with immunoglobulin and romiplostim
Romiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month. IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days. Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.
Sponsors
Qilu Hospital of Shandong University
Institute of Hematology & Blood Diseases Hospital, China
The First Affiliated Hospital of Soochow University
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Participants must sign a written informed consent prior to enrollment; 2. Ages 18-75; 3. Platelet count \<10×10\^9/L with active bleeding or bleeding score ≥5; 4. No contraindications to the use of steroids, romiplostim, or IVIG, and willingness to receive these treatments; 5. No prior splenectomy or at least one first-line ITP treatment or emergency treatment; 6. No prior romiplostim treatment; 7. ECOG PS score: 0-2; 8. Female participants of childbearing potential must agree to use reliable contraception (including male or female condoms, contraceptive foam, contraceptive jelly, contraceptive patches, contraceptive cream, contraceptive suppositories, abstinence, and placement of intrauterine contraceptive devices) throughout the study; women who have had a hysterectomy, bilateral oophorectomy, bilateral salpingo-oophorectomy, or have been postmenopausal for more than 1 year, and men who have had bilateral vasectomy or vasectomy are excluded; 9. Voluntary participation in this study and good compliance.
Exclusion criteria
1. Individuals with the following hematological disorders other than ITP, including but not limited to leukemia, thrombocytopenia caused by cancer treatment, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome; 2. Individuals with a history of thrombosis; 3. Pregnant or lactating individuals; 4. Individuals with severe cardiopulmonary insufficiency; 5. Individuals with severe or uncontrollable infections; 6. Individuals with viral infections; 7. Individuals who cannot comply due to psychological reasons; 8. Individuals who are deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total effective rate of treatment for 30 days | one months | GR = CR + R (Complete reaction CR, platelet count ≥ 100×10\^9/L, and no bleeding symptoms; Effective R, platelet count between 30×10\^9/L and 100×10\^9/L, and at least double the baseline value, and no bleeding symptoms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Early (week) response rate R | one months | Effective R, platelet count between 30×10\^9/L and 100×10\^9/L, and at least double the baseline value, and no bleeding symptoms |
| Early Complete Response Rate (CR) | one months | Complete reaction CR, platelet count ≥ 100×10\^9/L, and no bleeding symptoms |
| Time to Reaction | one months | Time of Starting Treatment Until Platelet Count ≥ 30×10\^9/L |
| Adverse events during treatment | four months | evaluated using Version 5.0 of the Common Terminology Criteria for Adverse Events(NCI CTC AE) |
Countries
China
Contacts
Primary ContactLiang Tang
Outcome results
None listed