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
Key facts
- Phase
- Phase 2
This trial has no sites in United States.
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Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
Source: NCT07400250, who can take part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Peking Union Medical College Hospital
- Trial code
- NCT07400250
- Record updated
- 10 February 2026
- Original description
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.Read full original descriptionShow less
Phase II Study of Orelabrutinib in Combination With Romiplostim in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received at Least One Prior Line of Therapy
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.
Inclusion: 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: Subjects develop intracranial hemorrhage within 6 months prior to screening; Subjects who, during the treatment period, require rescue therapy based on clinical assessment；; Subjects have other diseases which mention in protocol; Active and uncontrollable infection; Presence of other conditions, as determined by the investigator, that may affect the study results or lead to premature termination of the study；; Subjects have a history of coagulopathy other than ITP; 7. Subjects with a history of malignancies; 8. History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation; 9. Subjects with a known history of hypersensitivity to the investigational drug as described in the Protocol, or any ingredients; 10. Subjects with a Medication history and surgical history which mention in protocol; 11. Subjects do not meet the criterion of the laboratory test in protocol; Withdrawal Criteria:; 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 suffer from severe ITP at screening; Subjects who are unable to successfully undergo treatment tapering or discontinuation；; Subjects who withdraw their informed consent; Occurrence of pregnancy during the trial period; Poor subject compliance or a significant protocol violation；; Loss to follow-up；; The investigator decides that withdrawal is necessary for the subject's safety；; Study completion or early termination of the entire study.