Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia (ITP): A Multicenter, Interventional Trial
This prospective, multicenter, randomized study aim to evaluate the efficacy and safety of romiplostim N01 combined with glucocorticoids as the first-line treatment for newly diagnosed adult primary immune thrombocytopenia (ITP).
• Sign the written informed consent form before enrollment;
• Age ranging from 18 to 75 years old;
• Be clinically diagnosed with primary immune thrombocytopenia for less than 3 months before randomization;
• have not received any prior treatments for ITP.
• Have not received romiplostim treatment;
• ECOG PS score: 0 - 2;
• Platelet value \< 30×10\^9/L;
• The expected survival period at the screening is ≥ 12 weeks;
• 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;
⁃ Voluntarily join this study, sign the informed consent form, and have good compliance.