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

Starting soon · Phase 2

Conditions studied: Primary Immune Thrombocytopenia (ITP)

In brief

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.

Key facts

Study ID

NCT07400250

Run by

Peking Union Medical College Hospital

People needed

28

Starts

2026-04-01

Expected to finish

2028-10-01

Last updated by the study team

2026-02-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;
• 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 who are unable to successfully undergo treatment tapering or discontinuation；
• Subjects who, during the treatment period, require rescue therapy based on clinical assessment；
• 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；
• Presence of other conditions, as determined by the investigator, that may affect the study results or lead to premature termination of the study；
• Study completion or early termination of the entire study.

Where it is running

• Peking Union Medical College Hospital — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.