Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP

Launched by WUHAN UNION HOSPITAL, CHINA · Nov 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a combination treatment for adults with a severe condition called primary immune thrombocytopenia (ITP), which is when your body doesn't have enough platelets to help your blood clot properly. The trial will specifically look at how effective and safe the combination of three treatments—glucocorticoids (a type of steroid), gamma globulin (an immune system booster), and romiplostim N01 (a medication that helps increase platelet counts)—is when used together over a month.

To be eligible for this trial, participants need to be between 18 and 75 years old and have a very low platelet count, especially if they are experiencing active bleeding. They should not have any other serious blood disorders, recent history of blood clots, or certain health conditions that could complicate treatment. Participants will receive these medications through injections and infusions over the study period, and they will need to follow specific guidelines for participation, including using reliable birth control if applicable. This trial aims to find better ways to manage severe ITP and improve the safety and effectiveness of treatments for those affected.

Gender

ALL

Eligibility criteria

• 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.