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:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT04089267
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years old, male or female
* For patients who have been diagnosed with ITP, the diagnostic criteria are consistent with the Chinese Expert Consensus on Diagnosis and Treatment of Primary Immune Thrombocytopenia (2016 Edition)
* Recurrence after previous treatment with glucocorticoids is ineffective or effective
* No contraindications to rhTPO (Terbyus) application, and willing to accept rhTPO treatment
* Platelet count before enrollment ≤ 30 × 109 / L, or \> 30 × 109 / L but with active bleeding
* Volunteer to participate in the study and sign the informed consent form
Exclusion Criteria:
* pregnant or lactating
* Those with a history of thrombosis
* severe cardiopulmonary liver and kidney dysfunction: creatinine level ≥ 176.8μmol / l (2mg / dl), transaminase, bilirubin levels higher than the upper limit of the normal value of 3 times
* Those who have used rhTPO in the past 2 weeks, or who have undergone splenectomy within 2 months, or who have been treated with danazol for less than 1 month, or have recently applied the following ITP treatments but have not yet reached the efficacy judgment time. : C-ball (7 days), vincristine or vinblastine amide or rhIL-11 (2 weeks), Eltrombopag (1 month), or rituximab (2 months)
* In the case of previous treatment of rhTPO: rhTPO 300U/kg/d, 14 days of treatment is invalid;
* Severe or uncontrollable infections
* have a history of mental illness
* The investigator believes that the patient is not eligible to participate in any other circumstances of the trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04089267
Study Brief:
Protocol Section:
NCT04089267