Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07400250
Eligibility Criteria:
Inclusion Criteria:
1. Subjects voluntarily participate in this study and provide written informed consent；
2. Age 18-80 years, inclusive, regardless of gender；
3. ECOG score 0 to 2；
4. Documented diagnosis of chronic primary Immune Thrombocytopenia (ITP) with a disease duration \>12 months；
5. 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；
6. A history of response to prior standard ITP therapy (defined as achieving a platelet count ≥50×10⁹/L)；
7. 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；
8. 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:
1. Subjects suffer from severe ITP at screening;
2. Subjects have other diseases which mention in protocol;
3. Subjects develop intracranial hemorrhage within 6 months prior to screening;
4. Active and uncontrollable infection;
6\. 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:
1. 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；
2. Subjects who are unable to successfully undergo treatment tapering or discontinuation；
3. Subjects who, during the treatment period, require rescue therapy based on clinical assessment；
4. Subjects who withdraw their informed consent.
5. Occurrence of pregnancy during the trial period
6. Poor subject compliance or a significant protocol violation；
7. Loss to follow-up；
8. The investigator decides that withdrawal is necessary for the subject's safety；
9. Presence of other conditions, as determined by the investigator, that may affect the study results or lead to premature termination of the study；
10. Study completion or early termination of the entire study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07400250
Study Brief:
Protocol Section:
NCT07400250