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

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 monthsbefore randomization;

4. Have not received splenectomy or at least one first-line ITP treatment or emergencytreatment 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 measuresthroughout the study period (including male or female condoms, contraceptive foams,contraceptive gels, contraceptive membranes, contraceptive ointments, contraceptivesuppositories, abstinence, and intrauterine device placement, etc.); Female subjectswho have undergone hysterectomy, bilateral salpingectomy, bilateral tubal ligationor menopause for more than 1 year, and male subjects who have undergone bilateralvasectomy or ligation are excluded;

10. Voluntarily join this study, sign the informed consent form, and have goodcompliance.

Exclusion Criteria:

1. Suffering from other hematopoietic system diseases except ITP, including but notlimited to leukemia, thrombocytopenia caused by tumor treatment, myeloproliferativediseases, 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 firstadministration;

4. Having used drugs with c-Mpl (thrombopoietin receptor) stimulating effects within 4weeks before the first administration;

5. Having received hematopoietic growth factor preparations (such as granulocytecolony-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 thefirst administration;

7. Having received any Chinese herbal medicine or nutritional supplement (exceptvitamin supplements and mineral supplements) for the purpose of increasing plateletswithin 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 orcomplication of venous thrombosis (such as deep vein thrombosis, pulmonaryembolism), or using anticoagulants or antiplatelet drugs at the beginning ofscreening;

9. Having a history of severe cardiovascular diseases (such as grade III/IV congestiveheart failure, arrhythmia or angina pectoris that increases the risk ofthromboembolic events, unstable angina pectoris, having undergone coronary arterystent implantation, angioplasty or coronary artery bypass grafting);

10. Secondary thrombocytopenia caused by autoimmune diseases such as antiphospholipidantibody syndrome, systemic lupus erythematosus, Hashimoto's thyroiditis, Even'ssyndrome and Sjogren's syndrome;

11. Positive results for either human immunodeficiency virus antibody or syphilisantibody screening; positive hepatitis C antibody and HCV-RNA exceeding the upperlimit of the study center's laboratory test; positive hepatitis B surface antigenand 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 firstadministration;

13. Being pregnant or lactating, or having a pregnancy plan;

14. Having fertility and being judged by the researcher as not fully adoptingcontraceptive measures;

15. Having a history of severe drug allergic reactions or being known to be allergic toglucocorticoids 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;