A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP
Trial Parameters
Brief Summary
This study is a multicenter interventional research on the first-line treatment of newly diagnosed adult patients with immune thrombocytopenia (ITP) using romiplostim N01 in combination with glucocorticoids. The primary endpoint of this study is to assess the efficacy of romiplostim N01 combined with glucocorticoids in untreated newly diagnosed adult ITP patients after 6 months of administration. The subjects will be divided into the experimental group and the control group for treatment. Experimental group: Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously. Simultaneously, romiplostim N01 is administered at an initial dose of 3µg/kg, by subcutaneous injection, once a week, for a maximum of 6 months. Control group: Dexamethasone (HD-DXM) 40mg/d × 4 days, one cycle. If there is no response on the 10th day, repeat once, administered either orally or intravenously.
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 bil