Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immu… (NCT07400250) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy
China28 participantsStarted 2026-04-01
Plain-language summary
To evaluate whether orelabrutinib combined with romiplostim N01 can improve the quality of remission, increase the probability of successful drug withdrawal, and prolong the time to treatment failure in patients with primary immune thrombocytopenia (ITP) who have received at least one line of prior therapy.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Subjects voluntarily participate in this study and provide written informed consent；
✓. Age 18-80 years, inclusive, regardless of gender；
✓. ECOG score 0 to 2；
✓. Documented diagnosis of chronic primary Immune Thrombocytopenia (ITP) with a disease duration \>12 months；
✓. Patients with an inadequate sustained response, relapse, intolerance, or insufficient response to first-line ITP therapy (corticosteroids and/or intravenous immunoglobulin). Prior receipt of other ITP treatments is allowed, with no limit on the number of prior lines；
✓. A history of response to prior standard ITP therapy (defined as achieving a platelet count ≥50×10⁹/L)；
✓. During or following the most recent ITP treatment, patients must have experienced either: treatment failure (platelet count \<30×10⁹/L after treatment, or failure to double the baseline count, or occurrence of bleeding), relapse after initial response (platelet count decreased to \<30×10⁹/L, or fell below twice the baseline, or bleeding symptoms recurred), treatment intolerance, or an inability to maintain response after treatment discontinuation；
✓. Subjects demonstrate adequate comprehension of and are able to comply with the study protocol requirements, and are willing to complete the study according to the schedule.
Exclusion criteria
✕. Subjects suffer from severe ITP at screening;
✕. Subjects have other diseases which mention in protocol;
✕. Subjects develop intracranial hemorrhage within 6 months prior to screening;
✕. Active and uncontrollable infection;
✕. If, after 4 consecutive weeks of Romiplostim N01 administration at the maximum dose (10 µg/kg once weekly), the platelet count remains \<50×10⁹/L and the investigator judges the investigational product to be ineffective for the subject, such that continued use is not in the subject's best interest；
✕. Subjects who are unable to successfully undergo treatment tapering or discontinuation；
✕. Subjects who, during the treatment period, require rescue therapy based on clinical assessment；