First-line treatment for newly diagnosed adult patients with ITP using romiplostim

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

This study is testing if adding a new drug called romiplostim to the usual treatment can help adults who have just been diagnosed with immune thrombocytopenia feel better.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: rituximab
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT06658834 on ClinicalTrials.gov

What this trial studies

This multicenter interventional study evaluates the efficacy of romiplostim N01 combined with glucocorticoids in treating newly diagnosed adult patients with primary immune thrombocytopenia (ITP). Participants will be randomly assigned to either an experimental group receiving both romiplostim and dexamethasone or a control group receiving dexamethasone alone. The study aims to assess treatment outcomes after 6 months of administration. A total of 129 patients will be enrolled, and the study includes a screening, treatment, and follow-up period.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 who have been clinically diagnosed with primary immune thrombocytopenia for less than 3 months and have not received prior treatment.

Not a fit: Patients who have undergone splenectomy or have received any first-line ITP treatment prior to the study may not benefit from this trial.

Why it matters

Potential benefit: If successful, this treatment could improve platelet counts and overall management of ITP in newly diagnosed patients.

How similar studies have performed: Other studies have shown promise with similar approaches, but this specific combination of treatments is being evaluated for the first time in this context.

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;

Where this trial is running

Tianjin, Tianjin Municipality

• Chinese Academy of Medical Science and Blood Disease Hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Lei Zhang, MD

Conditions Primary Immune Thrombocytopenia; ITP; Romiplostim; Continuous Remission