A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP

Launched by INSTITUTE OF HEMATOLOGY & BLOOD DISEASES HOSPITAL, CHINA · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment option for adults who have recently been diagnosed with a condition called primary immune thrombocytopenia (ITP), which affects how your body produces platelets—cells that help your blood clot. The researchers want to see how effective the drug romiplostim N01, when used together with glucocorticoids (a type of steroid), is in treating this condition over a period of six months. Participants will be divided into two groups: one will receive the new drug along with steroids, and the other will only receive the steroids.

To be eligible for the trial, participants need to be between 18 and 75 years old, have a confirmed diagnosis of ITP for less than three months, and have a platelet count of less than 30. They should not have received any prior treatments for ITP or other specific medical conditions. If you choose to participate, you can expect to receive regular treatments and check-ups over the six months. It’s important to note that participants will need to provide informed consent, meaning they agree to join the study after understanding what it involves. This research could help improve treatment options for ITP in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Sign the written informed consent form before enrollment;
• • 2. Age ranging from 18 to 75 years old;
• • 3. Be clinically diagnosed with primary immune thrombocytopenia for less than 3 months before randomization;
• • 4. Have not received splenectomy or at least one first-line ITP treatment or emergency treatment in the past;
• • 5. Have not received romiplostim treatment;
• • 6. ECOG PS score: 0 - 2;
• • 7. Platelet value \< 30×10\^9/L;
• • 8. The expected survival period at the screening is ≥ 12 weeks;
• • 9. For subjects of reproductive age, agree to take reliable contraceptive measures throughout the study period (including male or female condoms, contraceptive foams, contraceptive gels, contraceptive membranes, contraceptive ointments, contraceptive suppositories, abstinence, and intrauterine device placement, etc.); Female subjects who have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligation or menopause for more than 1 year, and male subjects who have undergone bilateral vasectomy or ligation are excluded;
• • 10. Voluntarily join this study, sign the informed consent form, and have good compliance.
• Exclusion Criteria:
• • 1. Suffering from other hematopoietic system diseases except ITP, including but not limited to leukemia, thrombocytopenia caused by tumor treatment, myeloproliferative diseases, multiple myeloma and myelodysplastic syndrome, etc.;
• • 2. Having undergone splenectomy before the first administration;
• • 3. Having received ITP drug treatment (including emergency treatment) before the first administration;
• • 4. Having used drugs with c-Mpl (thrombopoietin receptor) stimulating effects within 4 weeks before the first administration;
• • 5. Having received hematopoietic growth factor preparations (such as granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11, etc.) within 4 weeks before the first administration;
• • 6. Having received antibody drugs (such as rituximab, etc.) within 14 weeks before the first administration;
• • 7. Having received any Chinese herbal medicine or nutritional supplement (except vitamin supplements and mineral supplements) for the purpose of increasing platelets within 1 week before the first administration;
• • 8. Having been diagnosed with arterial thrombosis (such as cerebral thrombosis, transient ischemic attack or myocardial infarction), or having a history or complication of venous thrombosis (such as deep vein thrombosis, pulmonary embolism), or using anticoagulants or antiplatelet drugs at the beginning of screening;
• • 9. Having a history of severe cardiovascular diseases (such as grade III/IV congestive heart failure, arrhythmia or angina pectoris that increases the risk of thromboembolic events, unstable angina pectoris, having undergone coronary artery stent implantation, angioplasty or coronary artery bypass grafting);
• • 10. Secondary thrombocytopenia caused by autoimmune diseases such as antiphospholipid antibody syndrome, systemic lupus erythematosus, Hashimoto's thyroiditis, Even's syndrome and Sjogren's syndrome;
• • 11. Positive results for either human immunodeficiency virus antibody or syphilis antibody screening; positive hepatitis C antibody and HCV-RNA exceeding the upper limit of the study center's laboratory test; positive hepatitis B surface antigen and HBV-DNA exceeding the upper limit of the study center's laboratory test;
• • 12. Having participated in other clinical studies within 3 months before the first administration;
• • 13. Being pregnant or lactating, or having a pregnancy plan;
• • 14. Having fertility and being judged by the researcher as not fully adopting contraceptive measures;
• • 15. Having a history of severe drug allergic reactions or being known to be allergic to glucocorticoids or Nplate® (romiplostim) or the components of QL0911;
• • 16. Unable to comply for mental reasons;
• • 17. Judged by the researcher as not suitable to participate in this trial;